BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW

    MDR report key: 3922943 · Received July 9, 2014

    Report

    Report Number
    1719045-2014-10300
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS RECEIVED CONDITION OF DEVICE; THE REPORTED SCREWDRIVER 387.284 IS PART OF THE CERVICAL SPINE LOCKING PLATE SYSTEM (CSLP) SYSTEM. IT WAS REPORTED THAT THE HANDLE BROKE WHEN BEING USED TO PLACE A LOCKING SCREW DURING A SURGICAL PROCEDURE. THE APPLICABLE TECHNIQUE GUIDES WERE REVIEWED. THIS SCREWDRIVER IS USED TO INSERT THE LOCKING SCREWS INTO THE EXPANSION-HEAD SCREWS. THESE DOCUMENTS RECOMMEND USING A COUNTER TORQUE WRENCH WITH THIS DRIVER TO OBTAIN THE MOST RIGID CONSTRUCT. UPON INSPECTION OF RECEIVED INSTRUMENT, THE REPORTED CONDITION IS CONFIRMED. THE DRIVER WAS RETURNED WITH THE HANDLE BROKEN IN THREE PIECES, ONCE ALL THE PIECES ARE PUT TOGETHER, A SMALL PORTION IS MISSING. A COMBINATION OF FACTORS HAS CONTRIBUTED TO THE HANDLE FRACTURING: EXTENSIVE USE DURING SERVICE LIFE, OFF-AXIS LOADING. THE PHENOLIC HANDLES OVER A PERIOD OF TIME CAN BECOME MORE BRITTLE DUE TO REPEATED STERILIZATION CYCLES AND USE. A REVIEW OF THE MOST RECENT APPLICABLE DRAWINGS WAS PERFORMED. THE DRAWING CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL DRIVER DESIGN. THE CURRENT INSTRUMENT DESIGN WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE AND THE INVOLVED DRIVER WAS MADE PRIOR THE CHANGE OF THE HANDLE MATERIAL. THE LOCKING SCREWS DICTATE THE DRIVER USE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.(B)(4).DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. ENVISION MANUFACTURING MANUFACTURED THE SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW THERE WERE NO COMPLAINT-RELATED ANOMALIES, MRRS, OR NCRS ASSOCIATED WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON FEBRUARY 15, 2002. THE SELF-RETAINING SCREWDRIVER WAS MANUFACTURED TO THE SYNTHES DRAWING NUMBER 387.284, REVISION ¿B¿, RELEASED ON AUGUST 17, 2000. 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

    IT WAS REPORTED THAT A CERVICAL SPINE LOCKING PLATE (CSLP) LOCKING SCREWDRIVER SHAFT BROKE THROUGH THE PHENOLIC HANDLE DURING ACTIVE USE, INTRA-OPERATIVELY. THE SCREWDRIVER BROKE WHILE PLACING A LOCKING SCREW. THE SCREWDRIVER BROKE INTO TWO PIECES, OVER THE PATIENT, BUT THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES. THE SURGERY WAS COMPLETED WITHOUT INCIDENT AND NO DELAY. ANOTHER SIMILAR SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE SURGERY BEING PERFORMED WAS A FOUR LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION USING A CSLP VARIABLE ANGLE FOUR LEVEL PLATE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400337 SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW TRAY, SURGICAL INSTRUMENT FSM SYNTHES MONUMENT 6818

    Patients

    Seq Age Sex Outcome Treatment
    1