BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM DRILL BIT/QC WITH 65MM STOP

    MDR report key: 3405894 · Received October 11, 2013

    Report

    Report Number
    1719045-2013-02003
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Report Date
    September 13, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. UNIQUE INSTRUMENTS (PRESENTLY ORCHID UNIQUE) MANUFACTURED THE 2.4 MM DRILL BIT/QU W/65 MM STOP, P/N 388.394, AND LOT NUMBER UN34615 FOR SYNTHES PO 432236. THE SUPPLIERS CERTIFICATE OF COMPLIANCE (DATED MAY 1, 2004) INDICATES THE PARTS WERE MANUFACTURED TO P/N 388.394 AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION (B)(4), REVISION AO (COMPLETED MAY 11, 2004). THERE WERE NO MRRS, NCRS, OR COMPLAINTS RELATED ISSUES WITH THIS LOT. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON BEGAN WITH DRILLING TWO HOLES IN C2 AND PLACING THE SCREWS. WHEN HE DRILLED THE FIRST HOLE IN C1 THE DRILL BIT BROKE IN THE BONE. THE PIECE WAS RETRIEVED AND THE SURGEON USED ANOTHER DRILL BIT TO CONTINUE. THE SURGEON ATTEMPTED TO PLACE A SCREW IN C1 AND THE HEAD OF THE SCREW BROKE OFF. THE SHAFT WAS REMOVED AND THE SURGEON USED A SECOND SCREW AND AGAIN THE HEAD BROKE OFF. HE REMOVED THE SHAFT AND PLACED A THIRD SCREW SUCCESSFULLY. THE SURGEON THEN COMPLETED THE PROCEDURE WITHOUT ANY DELAYS IN PROCEDURE TIME. LATER IN THE DAY THE PATIENT EXPERIENCED RESPIRATORY INSUFFICIENCY AND WAS PLACED ON A VENTILATOR. AFTER A FEW DAYS IN THE HOSPITAL ON THE VENTILATOR THE PATIENT PASSED AWAY. THIS REPORT IS 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523440 2.4MM DRILL BIT/QC WITH 65MM STOP HTW SYNTHES MONUMENT UN34615

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR