{ "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": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WARSAW", "manufacturer_contact_address_1": "700 ORTHOPAEDIC DR.", "manufacturer_contact_pcity": "30355268", "event_type": "Injury", "report_number": "1818910-2024-08026", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240422", "manufacturer_address_2": "", "pma_pmn_number": "K202769", "date_of_event": "20240304", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46581", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "3035526892", "noe_summarized": "1", "manufacturer_contact_l_name": "KARBERG", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "46581", "manufacturer_g1_state": "IN", "reporter_country_code": "US", "manufacturer_contact_area_code": "303", "date_added": "20240422", "manufacturer_contact_f_name": "KATE", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1686356", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240422", "brand_name": "VELYS SAW HANDPIECE", "generic_name": "INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT", "manufacturer_d_name": "DEPUY IRELAND", "manufacturer_d_address_1": "LOUGHBEG RINGASKIDDY CO.", "manufacturer_d_address_2": "", "manufacturer_d_city": "CORK", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "451570102", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10603295519430", "udi_public": "10603295519430", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Leak/Splash", "Leak/Splash" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "3035", "patient": [ { "patient_sequence_number": "1", "date_received": "20240422", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240410", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "19155406", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "46581", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "DEPUY ORTHOPAEDICS, INC.", "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": "340745852", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4)." }, { "mdr_text_key": "340791570", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. THIS EVENT WAS PREVIOUSLY REPORTED BY THE USER TO THE FDA UNDER NUMBERS MW5152693 AND MW5152694. SINCE THIS EVENT WAS ANONYMOUSLY REPORTED TO THE FDA, ALL REPORTER INFORMATION IS UNKNOWN. UDI: (B)(4). D4, H4: THE DEVICE SERIAL/LOT NUMBER AND DATE OF MANUFACTURE ARE UNKNOWN AT THIS TIME." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "700 ORTHOPAEDIC DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46581", "manufacturer_contact_exchange": "303", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }