BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3831538 · Received May 25, 2014

    Report

    Report Number
    2530088-2014-10135
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Report Date
    January 15, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED TWO SOCKET WRENCH DEVICES WERE NOT WORKING PROPERLY. ONE WRENCH HAD ITS WRENCH TEETH WORN COMPLETELY THROUGH FROM USE AND THE SECOND SAWS HANDLE BROKE DURING A SIMPLE OPERATION. THE PATIENT WAS NOT AFFECTED. NO PATIENT HARM. THE OPERATION WAS EXTENDED BY 20-30 MINUTES. THIS REPORT IS FOR THE WRENCH WITH THE WORN TEETH. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309750 SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS WRENCH HXC SYNTHES BRANDYWINE 5511542

    Patients

    Seq Age Sex Outcome Treatment
    1