{ "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": "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": "3005985723-2020-00332", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20201030", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20201006", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "AS", "manufacturer_contact_area_code": "", "date_added": "20201030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1225280", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201030", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "2555 DAVIE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "FORT LAUDERDALE", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33317", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33317", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07613327395280", "udi_public": "07613327395280", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Inappropriate Tactile Prompt/Feedback", "Unintended System Motion", "Inappropriate Tactile Prompt/Feedback" ], "reporter_state_code": "VI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/09/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20201030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "80 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20201204", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10766458", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201006", "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": "321766199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A PRIMARY RIGHT MAKO PKA 3.0 CASE THE ROBOTIC ARM LOCKED MID CASE. THE TIBIA AND POSTERIOR FEMORAL CUT WERE ALREADY PERFORMED. WHEN THE ERROR APPEARED ON SCREEN, THE ARM LOCKED JUST AS THE SURGEON WAS ABOUT TO BEGIN BURRING. I RELEASED THE ARM AND ADVISED THE SURGEON, TO RETURN THE ARM TO THE HOLSTER POSITION. I THEN MOVED THE ROBOT AWAY FROM THE OPERATING BED. I PERFORMED AN ¿ARM STATUS CHECK¿ WHICH SHOWED NO ERRORS. ON ATTEMPTING TO PROGRESS WITH THE CASE THE SAME ISSUE OCCURRED AGAIN. AT THIS POINT I CALLED FIELD SERVICE ENGINEER. SHE ADVISED THAT THE ERROR WAS MOST LIKELY RELATED TO A MOTOR OR ENCODER PROBLEM WHICH I WOULD NOT BE ABLE TO TROUBLESHOOT AND WHICH WOULD NEED TO BE SERVICED BY THE ENGINEERS. I INFORMED SURGEON OF THIS AND PUT FSE ON SPEAKER PHONE TO ALSO EXPLAIN THAT TO HIM. AS WE DO NOT HAVE CONVENTIONAL INSTRUMENTATION FOR PKAS, SURGEON MADE THE DECISION TO CONVERT TO A NAVIGATED TKA. I ASKED IF THE PATIENT WAS CONSENTED FOR THIS. HE UNSCRUBBED AND CALLED THE PATIENTS NOK TO OBTAIN CONSENT FOR THE TKA WHICH WAS GRANTED. STRYKER COLLEAGUE ATTENDED THE HOSPITAL TO ASSIST WITH THE CONVERTED TKA. WE PERFORMED A NAVIGATED TKA WHICH SURGEON WAS HAPPY WITH THE FINAL OUTCOME OF THE KNEE. THE FIELD SERVICE ENGINEER ARRIVED AT THE HOSPITAL WITHIN ONE HOUR AND PERFORMED DIAGNOSTIC INVESTIGATIONS ON THE ROBOT. THIS FOUND A PHASING ERROR AT JOINT 2 IN THE ARM WHICH HE WAS ABLE TO FIX BY RECALIBRATING THE JOINT. SURGICAL DELAY OF 1HR. CASE DURATION WAS TOTAL OF 3 HOURS." }, { "mdr_text_key": "321766200", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: IT WAS REPORTED, \" DURING A PRIMARY RIGHT MAKO PKA 3.0 CASE THE ROBOTIC ARM LOCKED MID CASE. THE TIBIA AND POSTERIOR FEMORAL CUT WERE ALREADY PERFORMED. WHEN THE ERROR APPEARED ON SCREEN, THE ARM LOCKED JUST AS THE SURGEON WAS ABOUT TO BEGIN BURRING. I RELEASED THE ARM AND ADVISED THE SURGEON (B)(6), TO RETURN THE ARM TO THE HOLSTER POSITION. I THEN MOVED THE ROBOT AWAY FROM THE OPERATING BED. I PERFORMED AN ¿ARM STATUS CHECK¿ WHICH SHOWED NO ERRORS. ON ATTEMPTING TO PROGRESS WITH THE CASE THE SAME ISSUE OCCURRED AGAIN. AT THIS POINT I CALLED (B)(6) (FIELD SERVICE ENGINEER). SHE ADVISED THAT THE ERROR WAS MOST LIKELY RELATED TO A MOTOR OR ENCODER PROBLEM WHICH I WOULD NOT BE ABLE TO TROUBLESHOOT AND WHICH WOULD NEED TO BE SERVICED BY THE ENGINEERS. I INFORMED (B)(6) OF THIS AND PUT (B)(6) ON SPEAKER PHONE TO ALSO EXPLAIN THAT TO HIM. AS WE DO NOT HAVE CONVENTIONAL INSTRUMENTATION FOR PKAS, (B)(6) MADE THE DECISION TO CONVERT TO A NAVIGATED TKA. I ASKED IF THE PATIENT WAS CONSENTED FOR THIS. HE UNSCRUBBED AND CALLED THE PATIENTS NOK TO OBTAIN CONSENT FOR THE TKA WHICH WAS GRANTED. VINCENT HUANG, MY STRYKER COLLEAGUE ATTENDED THE HOSPITAL TO ASSIST WITH THE CONVERTED TKA. WE PERFORMED A NAVIGATED TKA WHICH (B)(6) WAS HAPPY WITH THE FINAL OUTCOME OF THE KNEE. THE FIELD SERVICE ENGINEER ((B)(6)) ARRIVED AT THE HOSPITAL WITHIN ONE HOUR AND PERFORMED DIAGNOSTIC INVESTIGATIONS ON THE ROBOT. THIS FOUND A PHASING ERROR AT JOINT 2 IN THE ARM WHICH HE WAS ABLE TO FIX BY RECALIBRATING THE JOINT. SURGICAL DELAY OF 1HR. CASE DURATION WAS TOTAL OF 3 HOURS.¿ PRODUCT EVALUATION AND RESULTS: THE FIELD SERVICE ENGINEER REPORTED: CASE NUMBER: N/A, WORK ORDER: N/A. PROBLEM REPRODUCED? YES. TROUBLE SHOOTING NOTES: NONE. WORK PERFORMED: PERFORMED DIAGNOSTIC INVESTIGATIONS ON THE ROBOT. THIS FOUND A PHASING ERROR AT JOINT 2 IN THE ARM WHICH WAS FIXED BY RECALIBRATING THE JOINT. WORK ORDER DISPOSITION: SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR USE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE P/N: 219999, ROB WAS INSPECTED AND ACCEPTED INTO FINAL STOCK ON 27 NOVEMBER 2019 WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW : A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 219999, ROB SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION CONCLUSIONS: THE FAILURE WAS CONFIRMED THROUGH ONSITE FSE INSPECTION FROM THE FIELD SERVICE ENGINEER. THE FAILURE WAS RELATED TO A CALIBRATION ISSUE AND IT WAS RESOLVED BY RECALIBRATING THE JOINT. IT IS ALSO WORTH NOTING THAT THE SURGERY WAS CONVERTED TO A TKA. THIS WAS DUE TO THE UNAVAILABILITY OF CONVENTIONAL INSTRUMENTATION FOR A MANUAL PKA. THEREFORE THE HAZARD REPORTED AS PART OF THIS INVESTIGATION WAS RISK ASSESSED AGAINST THE REPORTED SURGICAL DELAY OF 1 HOUR RATHER THAN THE CONVERSION TO A TKA PROCEDURE. SUCCESSFULLY COMPLETED ALL CHECKS, VERIFICATIONS, AND CALIBRATIONS. SYSTEM IS READY FOR CLINICAL USE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "214150092", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "214150133", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A PRIMARY RIGHT MAKO PKA 3.0 CASE THE ROBOTIC ARM LOCKED MID CASE. THE TIBIA AND POSTERIOR FEMORAL CUT WERE ALREADY PERFORMED. WHEN THE ERROR APPEARED ON SCREEN, THE ARM LOCKED JUST AS THE SURGEON WAS ABOUT TO BEGIN BURRING. I RELEASED THE ARM AND ADVISED THE SURGEON, TO RETURN THE ARM TO THE HOLSTER POSITION. I THEN MOVED THE ROBOT AWAY FROM THE OPERATING BED. I PERFORMED AN ¿ARM STATUS CHECK¿ WHICH SHOWED NO ERRORS. ON ATTEMPTING TO PROGRESS WITH THE CASE THE SAME ISSUE OCCURRED AGAIN. AT THIS POINT I CALLED FIELD SERVICE ENGINEER. SHE ADVISED THAT THE ERROR WAS MOST LIKELY RELATED TO A MOTOR OR ENCODER PROBLEM WHICH I WOULD NOT BE ABLE TO TROUBLESHOOT AND WHICH WOULD NEED TO BE SERVICED BY THE ENGINEERS. I INFORMED SURGEON OF THIS AND PUT FSE ON SPEAKER PHONE TO ALSO EXPLAIN THAT TO HIM. AS WE DO NOT HAVE CONVENTIONAL INSTRUMENTATION FOR PKAS, SURGEON MADE THE DECISION TO CONVERT TO A NAVIGATED TKA. I ASKED IF THE PATIENT WAS CONSENTED FOR THIS. HE UNSCRUBBED AND CALLED THE PATIENTS NOK TO OBTAIN CONSENT FOR THE TKA WHICH WAS GRANTED. STRYKER COLLEAGUE ATTENDED THE HOSPITAL TO ASSIST WITH THE CONVERTED TKA. WE PERFORMED A NAVIGATED TKA WHICH SURGEON WAS HAPPY WITH THE FINAL OUTCOME OF THE KNEE. THE FIELD SERVICE ENGINEER ARRIVED AT THE HOSPITAL WITHIN ONE HOUR AND PERFORMED DIAGNOSTIC INVESTIGATIONS ON THE ROBOT. THIS FOUND A PHASING ERROR AT JOINT 2 IN THE ARM WHICH HE WAS ABLE TO FIX BY RECALIBRATING THE JOINT. SURGICAL DELAY OF 1HR. CASE DURATION WAS TOTAL OF 3 HOURS." } ], "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": "12/05/2020" } ] }