BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN- 3.2 X 140MM- STERILE (2 PACK)

    MDR report key: 5138081 · Received October 8, 2015

    Report

    Report Number
    3005985723-2015-00184
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: DURING PARTIAL KNEE REPLACEMENT SURGERY, ALL FOUR TIPS OF THE 3.2X140MM BONE PINS BROKE OFF AND EMBEDDED IN PATIENT. THIS WAS DISCOVERED AFTER THE CASE AND THE BONE PINS WERE NOT RETRIEVED FOR THE INVESTIGATION. DEVICE EVALUATION AND RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES ((B)(4) NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND SHIPPED TO (B)(6) ON 06/11/2015 AND ACCEPTED INTO FINAL STOCK ON 06/11/2015 PER (B)(4). COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 111620, LOT NUMBER W39913 SHOWS (B)(4) ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. SEE PR ID (B)(4) FOR OTHER COMPLAINTS RELATED TO THIS LOT. AT THE TIME OF THIS INVESTIGATION, (B)(4) HAS BEEN COMPLETED. TRACKING OF COMPLAINTS RELATED TO THE 111620 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST # (B)(4). CONCLUSIONS: AS PART OF THE INVESTIGATION INTO THIS COMPLAINT, THE STRYKER REP THAT WAS PRESENT FOR THE CASE WAS CONTACTED ON FIVE SEPARATE OCCASIONS. AFTER THESE ATTEMPTS TO DETERMINE IF THE DRILL GUIDE WAS USED DURING PLACEMENT OF THE BONE PINS (FINAL ATTEMPT WAS (B)(6) 2016) NO RESPONSE WAS RECEIVED. IT CANNOT BE DETERMINED IF THE SURGEON USED THE DRILL GUIDE DURING PLACEMENT OF THE BONE PINS. HOWEVER, TO DATE (B)(4) COMPLAINT INVESTIGATIONS HAVE BEEN COMPLETED FOR THIS PART NUMBER. OF THOSE (B)(4) COMPLAINT INVESTIGATIONS, NO COMPLAINTS HAVE BEEN INVESTIGATED WHERE THE BONE PINS WERE INSERTED USING A DRILL GUIDE AND WERE BROKEN INTRAOPERATIVE. IT IS POSSIBLE THAT THE SURGEON DID NOT USE THE DRILL GUIDE DURING THE PLACEMENT OF THE BONE PINS AS THE DEVICES WERE WITHIN SPECIFICATION ACCORDING TO THE DHR DOCUMENTATION . CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE TIPS OF THE BONE PINS BROKE BELOW SURFACE OF THE BONE WHILE THE SURGEON WAS DRILLING INTO THE PATIENT'S TIBIA AND FEMUR. THE SURGEON DECIDED TO LEAVE THE TIP OF THE BONE PIN IN THE PATIENT'S BONE. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE TIPS OF THE BONE PINS BROKE BELOW SURFACE OF THE BONE WHILE THE SURGEON WAS DRILLING INTO THE PATIENT'S TIBIA AND FEMUR. THE SURGEON DECIDED TO LEAVE THE TIP OF THE BONE PIN IN THE PATIENT'S BONE. THE OUTCOME OF THE CASE WAS SUCCESSFUL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669237 BONE PIN- 3.2 X 140MM- STERILE (2 PACK) STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. N/A W39913-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention