BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM UNIVERSAL DRILL GUIDE

    MDR report key: 3020337 · Received March 25, 2013

    Report

    Report Number
    8030965-2013-01137
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    February 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PRODUCT WAS DISCARDED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES DURING PROCEDURE T-HANDLE WITH QUICK COUPLING DID NOT CONNECT WITH DRILL GUIDE, AND WHERE THE DRILL GUIDE FELL APART. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122796 2.7MM UNIVERSAL DRILL GUIDE GUIDE FZX SYNTHES GMBH 3823439

    Patients

    Seq Age Sex Outcome Treatment
    1