{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 37471 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9680825-2020-00034", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K161466", "date_of_event": "20200413", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "DISTRIBUTOR", "FOREIGN" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464970", "implant_date_year": "2020", "date_removed_year": "2020", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "CHIMAERA HFS LONG NAIL RIGHT 125 L340MM D11MM STERILE", "generic_name": "CHIMAERA HFS LONG NAIL RIGHT 125 ° L340MM D11MM STERILE", "manufacturer_d_name": "ORTHOFIX SRL", "manufacturer_d_address_1": "VIA DELLE NAZIONI, 9", "manufacturer_d_address_2": "", "manufacturer_d_city": "BUSSOLENGO, VERONA,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "37012", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "IT", "manufacturer_d_postal_code": "37012", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210604", "model_number": "99-T932340R", "catalog_number": "99-T932340R", "lot_number": "B1010983", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200507", "device_report_product_code": "HSB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "18054242514435", "udi_public": "(01)18054242514435(11)160704(17)210604(10)B1010983", "openfda": { "registration_number": [ "9680825" ], "fei_number": [ "3002807827" ], "device_name": "Rod, Fixation, Intramedullary And Accessories", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3020", "device_class": "2" } } ], "product_problems": [ "Break", null, "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/10/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "82", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200617", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000665", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200416", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318216913", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 99-T932340R LOT NUMBER B1010983 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF 7 NAILS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICE, RECEIVED ON MAY 7, 2020, WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: THE NAIL IS BROKEN IN CORRESPONDENCE OF ONE PROXIMAL HOLE. THE DEVICE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR THE RAW MATERIAL CHECK AND THE FAILURE ANALYSIS. THE CHEMICAL AND MECHANICAL ANALYSIS EVIDENCED THAT THE RETURNED NAIL WAS ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATIONS. THE NAIL BROKE DUE TO BENDING FATIGUE FAILURE, NUCLEATING IN CORRESPONDENCE OF A SURFACE DAMAGE. THIS DAMAGE IS MOST LIKELY ATTRIBUTABLE TO MECHANICAL DAMAGE OCCURRED DURING PRE-DRILLING ACTIVITIES. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. - (B)(6), 2020: \"IN THIS CASE A CHIMAERA NAIL WAS INSERTED INTO A RIGHT FEMUR TO STABILISE A SUBTROCHANTERIC FRACTURE, ON FEBRUARY 6TH, IN A MALE OF 82 KG. THE REDUCTION WAS STRENGTHENED WITH 3 CERCLAGE WIRES. 2 MONTHS LATER THE NAIL BROKE AT THE JUNCTION WITH THE LARGE LAG SCREW. IT WAS REPLACED WITH AN I/M NAIL. I ASSUME THAT THE X-RAY WITH THE INTACT NAIL IS THE POSTOPERATIVE ONE, BUT IT IS JUST POSSIBLE THAT IT SHOWS A REPLACEMENT CHIMAERA NAIL. IT IS DIFFICULT TO SAY WHY THIS HAPPENED TO THIS PATIENT. I NOTE THAT THE PATIENT HAS CHRONIC OBSTRUCTIVE AIRWAYS DISEASE GRADE 2-3 AND DIABETES TYPE 2. HE HAD A BROKEN NAIL REPLACED WITH ANOTHER IMPLANT AND FOR THE PATIENT ALL SHOULD NOW BE WELL\". - (B)(6), 2020 WITH THE OUTCOME OF THE TECHNICAL ANALYSIS: \"IT IS VERY CLEAR THAT THE DEVICE WAS ORIGINALLY FULLY TO SPECIFICATION, AND THAT THE BREAKAGE WAS SUDDEN WITH LITTLE DEFORMATION. I AGREE THAT IT IS VERY LIKELY THAT THE BREAKAGE ORIGINATED IN AN AREA OF ACCIDENTAL DAMAGE DURING IMPLANTATION. I FULLY AGREE WITH THE CONCLUSIONS OF THE TECHNICAL ANALYSIS\". CONCLUSION THE RESULTS OF THE TECHNICAL INVESTIGATION INDICATED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO ORTHOFIX SRL SPECIFICATIONS. THE NAIL BROKE DUE TO BENDING FATIGUE FAILURE, NUCLEATING IN CORRESPONDENCE OF A SURFACE DAMAGE, WHICH IS MOST LIKELY TO BE ATTRIBUTABLE TO MECHANICAL DAMAGE OCCURRED DURING PRE-DRILLING ACTIVITIES. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: \"IN THIS CASE A CHIMAERA NAIL WAS INSERTED INTO A RIGHT FEMUR TO STABILISE A SUBTROCHANTERIC FRACTURE, ON FEBRUARY 6TH, IN A MALE OF 82 KG. THE REDUCTION WAS STRENGTHENED WITH 3 CERCLAGE WIRES. 2 MONTHS LATER THE NAIL BROKE AT THE JUNCTION WITH THE LARGE LAG SCREW. IT WAS REPLACED WITH AN I/M NAIL. I ASSUME THAT THE X-RAY WITH THE INTACT NAIL IS THE POSTOPERATIVE ONE, BUT IT IS JUST POSSIBLE THAT IT SHOWS A REPLACEMENT CHIMAERA NAIL. IT IS DIFFICULT TO SAY WHY THIS HAPPENED TO THIS PATIENT. I NOTE THAT THE PATIENT HAS CHRONIC OBSTRUCTIVE AIRWAYS DISEASE GRADE 2-3 AND DIABETES TYPE 2. HE HAD A BROKEN NAIL REPLACED WITH ANOTHER IMPLANT AND FOR THE PATIENT ALL SHOULD NOW BE WELL. IT IS VERY CLEAR THAT THE DEVICE WAS ORIGINALLY FULLY TO SPECIFICATION, AND THAT THE BREAKAGE WAS SUDDEN WITH LITTLE DEFORMATION. I AGREE THAT IT IS VERY LIKELY THAT THE BREAKAGE ORIGINATED IN AN AREA OF ACCIDENTAL DAMAGE DURING IMPLANTATION. I FULLY AGREE WITH THE CONCLUSIONS OF THE TECHNICAL ANALYSIS\". BASED ON THE RESULTS OF THE TECHNICAL INVESTIGATION PERFORMED ON THE RETURNED NAIL AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE BREAKAGE THAT OCCURRED IS NOT DEVICE-RELATED. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. - ATTACHMENT: [2020068_FDA MEDWATCH COVER LETTER_FOLLOW UP 1.PDF]." }, { "mdr_text_key": "318216914", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-T932340R (CHIMAERA HFS LONG NAIL RIGHT 125 ° L340MM D11MM STERILE) - BATCH NUMBER: B1010983 - QUANTITY: 1 - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2020 - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR - SURGERY DESCRIPTION: FRACTURE TREATMENT - PATIENT'S INFORMATION: (B)(6). - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: OTHER, SEE EVENT DESCRIPTION - EVENT DESCRIPTION: \"BREAKAGE OF THE UPPER END OF THE NAIL. NECESSITY OF 2ND OPERATION WITH REDUCTION AND INTRAMEDULLARY NAIL FIXATION\". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION, LOSS OF ACHIEVED CORRECTION) - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6) 2020) - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED (PERFORMED ON (B)(6) 2020) - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAY IMAGES ARE AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN - PATIENT CURRENT HEALTH CONDITIONS: PATIENT IS RECOVERING FROM 2ND OPERATION. MANUFACTURER REF: (B)(4)." }, { "mdr_text_key": "190020116", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 99-T932340R LOT NUMBER B1010983 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF 7 NAILS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET." }, { "mdr_text_key": "190020117", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-T932340R (CHIMAERA HFS LONG NAIL RIGHT 125 ° L340MM D11MM STERILE). BATCH NUMBER: B1010983. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6) YEARS, MALE, (B)(6) KG, 170 CM, WITH COPD II-III AND D.M. II. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: OTHER, SEE EVENT DESCRIPTION. EVENT DESCRIPTION: \"BREAKAGE OF THE UPPER END OF THE NAIL. NECESSITY OF 2ND OPERATION WITH REDUCTION AND INTRAMEDULLARY NAIL FIXATION\". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION, LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6) 2020). A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED (PERFORMED ON (B)(6) 2020). COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITIONS: PATIENT IS RECOVERING FROM 2ND OPERATION. MANUFACTURER REF: (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/22/2020" } ] }