BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 3845046 · Received June 3, 2014

    Report

    Report Number
    0002249697-2014-02042
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN (B)(4) OTHER EVENT REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SCREWDRIVER TIP BROKE OFF IN SCREW DURING SURGERY. COULD NOT REMOVE SCREW. HAD TO BREAK OFF PART OF SCREW HEAD TO SEAT LINER IN CUP.

    Description of Event or Problem · 1

    SCREWDRIVER TIP BROKE OFF IN SCREW DURING SURGERY. COULD NOT REMOVE SCREW. HAD TO BREAK OFF PART OF SCREW HEAD TO SEAT LINER IN CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324271 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F8V745402

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other