BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE, G3 PLUS

    MDR report key: 4793372 · Received May 22, 2015

    Report

    Report Number
    0009610622-2015-00262
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    STRYKER TRAUMA KIEL (MDR)
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE HAD ALREADY BEEN EXAMINED DURING COMPLAINT INVESTIGATION OF PI # 844132 AS THE SAME TARGET DEVICE HAD LED TO TWO EVENTS IN THE SAME HOSPITAL ON THE SAME DAY. INVESTIGATION HAD REVEALED THAT THE FUNCTION OF THE TARGET DEVICE RECEIVED WAS STILL FULLY GIVEN. THE EVENT REPORTED (¿¿SCREW MISSED THE DISTAL HOLE OF THE NAIL ¿) DURING DISTAL LOCKING COULD NOT BE CONFIRMED OR REPRODUCED. POTENTIALLY REDUCED ACCURACY IN GUIDANCE IS USUALLY FOUND DURING FUNCTIONAL CHECK (REQUIRED PER IFU). IN CASE OF ANY DEVIATION IT IS REALIZED PRIOR TO USE. PRE-SUPPOSING THAT TARGETING ACCURACY FOR DRILLING WAS CONFIRMED BY PRE-OPERATIVE CHECK IT WAS CONCLUDED THAT THE EVENT(S) WERE MAINLY BASED IN THE INTRA-OPERATIVE PROCEDURE. REASONS FOR MISALIGNED DRILLING ARE VARIOUS. POTENTIAL MISS-TARGETING CAN ALSO BE CAUSED BUT IS NOT LIMITED BY E.G., LOOSENING OF THE NAIL HOLDING BOLT DURING INSERTION OF THE NAIL, REPEATED TIGHTENING OF THE NAIL HOLDING SCREW PRIOR TO DISTAL TARGETING / DRILLING IS RECOMMENDED, NOT REALIZED UNINTENDED LOOSENING OF THE ATTACHMENT KNOB (WILL LEAD TO RELEASE OF THE DRILL SLEEVE), NO USE OF DRILL WITH CENTER TIP / UNFAVORABLE BONE CONTOUR, DRILLING WITHOUT DRILL GUIDING SLEEVE, USING BLUNT OR DAMAGED DRILL, HIGH FORCES APPLIED TO THE TARGET DEVICE DURING DRILLING EVENTUALLY LEADING TO UNINTENDED DISTORTION IN THE SYSTEM OF DRILL, SLEEVE, TARGET DEVICE AND NAIL. ALTHOUGH A REAL ROOT CAUSE COULD NOT BE DETERMINED THE ALLEGED EVENT WAS MOST LIKELY CAUSED DUE TO A SUB-OPTIMAL INTRA-OPERATIVE PROCEDURE. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHEN USING A SHORT GAMMA NAIL ON A GAMMA PLUS TARGETOR, THE SCREW MISSED THE DISTAL HOLE OF THE NAIL. IT WAS ON A WEEKEND AND NO REP WAS CALLED IN SO NO STRYKER EMPLOYEE WITNESSED THE EVENT. AS PER NEW INFORMATION RECEIVED: "SCREW IS NOT IN THE PATIENT, THE SCREW AND SHORT NAIL WAS TAKEN OUT AND A LONG GAMMA WAS IMPLANTED."

    Description of Event or Problem · 1

    WHEN USING A SHORT GAMMA NAIL ON A GAMMA PLUS TARGETOR, THE SCREW MISSED THE DISTAL HOLE OF THE NAIL. IT WAS ON A WEEKEND AND NO REP WAS CALLED IN SO NO STRYKER EMPLOYEE WITNESSED THE EVENT. AS PER NEW INFORMATION RECEIVED: "SCREW IS NOT IN THE PATIENT, THE SCREW AND SHORT NAIL WAS TAKEN OUT AND A LONG GAMMA WAS IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336839 TARGET DEVICE, G3 PLUS INSTRUMENT LXH STRYKER TRAUMA KIEL (MDR) KME901925

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other