BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTRAINED LINER INSERTER IMPACTOR TIP 22MM

    MDR report key: 2930488 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00334
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DHR INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CHR INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL INSPECTION OF RETURNED DEVICE CONFIRMED THE EVENT. A LARGE SHARD OF PLASTIC FRACTURED FROM DEVICE IN REGION OF THREADED MATING HOLE. DAMAGE TO DEVICE SUGGESTS MATING IMPACTOR HANDLE WAS NOT FULLY ATTACHED TO SUBJECT DEVICE PRIOR TO IMPACTION. MATERIAL ANALYSIS FOUND NO MATERIAL OR MANUFACTURING DEFECTS ON FRACTURE SURFACES EXAMINED. THE INVESTIGATION CONCLUDED THAT IMPACTOR TIP DAMAGE WAS CAUSED BY USER MISUSE. THE IMPACTOR TIP WAS NOT FULLY THREADED ON IMPACTOR HANDLE BEFORE USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A REVISION FOR A DISLOCATING/DISASSOCIATING RIGHT HIP. SURGEON REMOVED LINER WHICH WAS DISASSOCIATING FROM CUP AND WHILE SURGEON WAS IMPLANTING A NEW CONSTRAINED LINER, WHILE USING THE LINER IMPACTION TOOL, THE TOOL BROKE - A LARGE PORTION OF THE IMPACTOR BROKE OFF AND WOULD NO LONGER THREAD INTO THE HANDLE. SURGEON USED THE LARGER HEAD IMPACTOR AND COMPLETED THE CASE WITHOUT ANY DELAY OR INTERRUPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A REVISION FOR A DISLOCATING/DISASSOCIATING RIGHT HIP. SURGEON REMOVED LINER WHICH WAS DISASSOCIATING FROM CUP AND WHILE SURGEON WAS IMPLANTING A NEW CONSTRAINED LINER, WHILE USING THE LINER IMPACTION TOOL, THE TOOL BROKE - A LARGE PORTION OF THE IMPACTOR BROKE OFF AND WOULD NO LONGER THREAD INTO THE HANDLE. SURGEON USED THE LARGER HEAD IMPACTOR AND COMPLETED THE CASE WITHOUT ANY DELAY OR INTERRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37970 CONSTRAINED LINER INSERTER IMPACTOR TIP 22MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH KPWMED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other