BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.3MM PERCUTANEOUS THREADED DRILL GUIDE

    MDR report key: 2993697 · Received March 7, 2013

    Report

    Report Number
    2520274-2013-01354
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS EXAMINED AND NO VISIBLE DAMAGES WERE NOTED. THE THREADS OF BOTH GUIDES WERE CHECKED WITH THE SCREW PLUG GAUGE (B)(4) AND NO DEVIATION WAS FOUND. THE THREADS ARE FUNCTIONAL AS REQUIRED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS 4 OF 5 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013 THE FOLLOWING PROBLEMS WERE ENCOUNTERED WITH THE LCP PERIARTICULAR AIMING INSTRUMENT DURING AN ORIF TIBIAL FRACTURE PROCEDURE. WHILE TRYING TO ENGAGE THREADED DRILL GUIDES INTO PLATE USING PERCUTANEOUS HANDLES FOR DRILL GUIDES, THE HANDLES BECAME STRIPPED AND WOULD NOT ENGAGE IN THE WAY THAT THEY ARE INTENDED TO. IN ORDER TO COMPLETE THE OPERATION, THE SURGEON HAD TO USE THE HANDLE AS A WRENCH ON THE SIDE OF EACH DRILL GUIDE IN ORDER TO FULLY TIGHTEN. THE SURGERY WAS PROLONGED AN ADDITIONAL 15 MINUTES. THIS IS 4 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96705 4.3MM PERCUTANEOUS THREADED DRILL GUIDE FZX SYNTHES USA 3092549

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR