BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 LONG F/MATRIX

    MDR report key: 3171649 · Received June 15, 2013

    Report

    Report Number
    1719045-2013-01611
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE SCREWDRIVER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS A REVIEW OF THE DEVICE HISTORY RECORD. NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. IT IS CLEARLY VISIBLE THAT ONLY THE FIRST MILLIMETER OF THE TIP WAS DEFORMED, THIS IS A CLEAR INDICATION THAT THE SCREWDRIVER WAS NOT COMPLETELY INSERTED INTO THE RECESS OF THE LOCKING CAP. BY THIS THE TORQUE WAS NOT ALLOCATED ON THE COMPLETE STAR DRIVE AS DESIGNED, THIS LEAD TO THE COMPLAINED MALFUNCTION AND FINALLY TO THE DEFORMATION OF THE FORE FRONT OF THE TIP.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A MATRIX SURGERY ON AN UNKNOWN DATE, THE TIP OF THE STARDRIVE SCREWDRIVER SHAFT WAS DEFORMED AND PARTS OF THE THREADS BROKE OFF. THIS HAPPENED DURING FINAL TIGHTENING WITH COUNTER TORQUE AND T- HANDLE WITH RATCHET WRENCH AND TORQUE LIMITER AND SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272523 SCRDRIVERSHAFT T25 LONG F/MATRIX HXX SYNTHES MONUMENT 6515680

    Patients

    Seq Age Sex Outcome Treatment
    1