BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 140MM, STERILE 2 PACK

    MDR report key: 6269730 · Received January 23, 2017

    Report

    Report Number
    3005985723-2017-00030
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    January 18, 2017
    Report Date
    July 24, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, AU
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE, 3.2MM X 140MM BONE PIN, WAS NOTICED TO HAVE FRACTURED IN THE FEMUR WHEN REMOVING THE PIN. THE TIP OF THE PIN WAS LEFT IN THE FEMUR. THERE WAS A 20 MINUTE SURGICAL DELAY FOR X-RAY. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN STRYKER'S DATABASE RELATED TO P/N 143140, LOT NUMBER W43264 SHOWS 4 ADDITIONAL COMPLAINT INVESTIGATIONS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE INVESTIGATIONS ARE: PR 1161126, PR 1276688, PR 1321801 AND PR 1321820. TRACKING OF COMPLAINTS RELATED TO THE 143140 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #789. CONCLUSIONS: THE FAILURE WAS CONFIRMED WITHOUT THE EVALUATION OF THE RETURNED DEVICE. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN ONE CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THE CAPA COMPLETED IN THE CATSWEB SYSTEM IS CAPA (B)(4). 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). UPON REMOVING THE 3.2MM X 140MM PIN FROM THE FEMUR IN THE MAKO PARTIAL KNEE CASE, THE SURGEON NOTICED THE PIN HAD BROKEN OFF IN THE PATIENT. THE SURGEON CALLED IN XRAY INTRAOPERATIVELY AND FOUND PIECES OF THE PIN SNAPPED OFF IN THE FEMUR. HE LEFT THE REMNANTS IN THE PATIENT AND WAS NOT CONCERNED. HE GAVE FEEDBACK THAT HE HAD REMOVED THAT PIN ON INITIAL INSERTION AND REINSERTED WITHOUT CHECKING THE INTEGRITY OF THE PIN.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). UPON REMOVING THE 3.2MM X 140MM PIN FROM THE FEMUR IN THE MAKO PARTIAL KNEE CASE, THE SURGEON NOTICED THE PIN HAD BROKEN OFF IN THE PATIENT. THE SURGEON CALLED IN XRAY INTRAOPERATIVELY AND FOUND PIECES OF THE PIN SNAPPED OFF IN THE FEMUR. HE LEFT THE REMNANTS IN THE PATIENT AND WAS NOT CONCERNED. HE GAVE FEEDBACK THAT HE HAD REMOVED THAT PIN ON INITIAL INSERTION AND REINSERTED WITHOUT CHECKING THE INTEGRITY OF THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53095 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W43264

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other