BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR SCREWS: 2.7/3.5/4.0MM

    MDR report key: 1983768 · Received January 20, 2011

    Report

    Report Number
    8031020-2011-00015
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, DEPTH GAUGE HAS BROKEN OFF AT THE STARTING POINT OF THE DEPTH GAUGE FEELER WHICH IS AFTER THE DEPTH GAUGE RULER PART. THIS DID NOT EFFECT THE SURGERY CASE. INSTR. WORN DOWN AFTER USAGE AND AUTOCLAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH GAUGE FOR SCREWS: 2.7/3.5/4.0MM INSTRUMENT HWC STRYKER OSTEOSYNTHESIS SELZACH NA 007324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other