BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE SLEEVE FOR LAG SCREW 10.5X268 MM

    MDR report key: 1850019 · Received September 27, 2010

    Report

    Report Number
    9610622-2010-00403
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NURSE, HEAD OF THEATRE, REPORTS VIA FAX THAT THE DRILL GUIDE SLEEVE IS DEFORMED ALTHOUGH IT WAS NOT YET USED. MOREOVER, SHE WRITES THAT IT WAS DETECTED DURING PREPARATION FOR USE AND THAT THE SURGERY WAS POSTPONED TO THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL GUIDE SLEEVE FOR LAG SCREW 10.5X268 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other