BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHANZ SCREW

    MDR report key: 2923238 · Received January 18, 2013

    Report

    Report Number
    2520274-2013-00499
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO CATALOG NUMBER OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    WHILE CUTTING A SHANZ PIN INTRA-OPERATIVELY THE PIN BECAME COLD WELDED TO THE BOLT CUTTING HEAD AND COULD NOT BE REMOVED. THE BOTTOM OF THE DEVICE BROKE OFF. THIS IS # 2 OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27266 SCHANZ SCREW SCHANZ SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTER