BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMER GUIDE F/TEN

    MDR report key: 2870602 · Received December 12, 2012

    Report

    Report Number
    8030965-2012-01566
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION HAS SHOWED CONFORMITY OF THE PART TO SPECIFICATIONS. THE THREAD OF THE HAMMER GUIDE IS DAMAGED DUE TO EXCEEDING APPLIED MECHANICAL FORCE. IT IS POSSIBLE THE THREAD WAS NOT SCREWED IN FAR ENOUGH AND WAS DAMAGED. THE MARKS FOUND ON THE HEAD OF THE GUIDE GIVE US A CLEAR INDICATION THAT THE SLOTTED HAMMER HAS NOT BEEN USED ACCORDINGLY, WHICH IS CONSIDERED A HANDLING FAULT. THERE IS NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE HAMMER DID NOT WORK PROPERLY. THE SPECIALIST EXPRESSED THAT WHEN INSERTING THE TEN DEVICE, THE INSERTION INSTRUMENTS DID NOT WORK; WERE VISIBLY DAMAGED AND DETERIORATED. HE HAD TO PERFORM THE INSERTION WITH PLIERS. THE SURGERY WAS PERFORMED IN 3 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMMER GUIDE F/TEN HAMMER GUIDE LXH SYNTHES GMBH 7505392

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HAMMER GUIDE, TEN