BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE U-JOINT DRIVER

    MDR report key: 1062157 · Received June 13, 2008

    Report

    Report Number
    1719045-2008-00077
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. SUBJECT DEVICE WAS REC'D AND EVALUATED. THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES. MECHANICAL OVERLOADING POSSIBLY LEAD TO THE BREAKAGE. REVIEW OF THE MFG RECORDS FOUND NO COMPLAINT-RELATED ISSUES.

    Description of Event or Problem · 1

    THE STARDRIVE ON A LOW PROFILE U-JOINT DRIVER BROKE OFF INSIDE THE HEAD OF A SCREW. THE BROKEN FRAGMENT COULD NOT BE REMOVED, SO THE SURGEON PUT BONE WAX OVER THE BROKEN FRAGMENT. THE SURGEON HAS NO PLANS TO EXPLANT THE BROKEN FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE U-JOINT DRIVER LOW PROFILE U-JOINT DRIVER LXH SYNTHES (USA) NA 2331810

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SCREW| BONE WAX