BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF QUICK COUPLING FOR DRILL BITS

    MDR report key: 3173021 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03288
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED ORTHOPEDIC SURGERY ON (B)(6) 2013, THE SURGEON WAS HAVING DIFFICULTY LOCKING AND UNLOCKING THE BIT FROM THE COUPLING. THE SURGERY WAS NOT PROLONGED AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273783 AO/ASIF QUICK COUPLING FOR DRILL BITS HWE SYNTHES GMBH 3921

    Patients

    Seq Age Sex Outcome Treatment
    1