BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER FOR SYNFIX(TM)-LR

    MDR report key: 3003780 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-10495
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    December 6, 2011
    Report Date
    December 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED AND THE TIP OF THE RETURNED SCREWDRIVER WAS FRACTURED, WITH ONE OF THE SIX STARDRIVE TIPS BROKEN OFF ABOVE THE RETENTION PIN CONTAINED WITHIN THE TIP. THE PINS OF THE CARDAN JOINT WERE ALSO BENT AND WORN. A MANUFACTURING EVALUATION WAS PERFORMED. THE RELEVANT DIMENSIONS COULD NOT BE CHECKED DUE TO DEVICE DAMAGE. THE COMPLAINT WAS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. A DESIGN EVALUATION WAS PERFORMED AS PART OF THE PRODUCT DEVELOPMENT ANALYSIS. BASED ON PREVIOUS TESTING OF A SIMILAR DEVICE, THIS DESIGN WAS DETERMINED TO BE ACCEPTABLE FOR ITS INTENDED USE. THE CURRENT TECHNIQUE GUIDE HAS A WARNING STATING THAT "EXCESSIVE TORQUE CAN DAMAGE OR BREAK THE INSTRUMENTS OR IMPLANT. USE FOUR FINGERS FOR FINAL TIGHTENING." THE FRACTURE OF THE SCREWDRIVER TIP WAS MOST LIKELY A RESULT OF MISUSE OR EXCESSIVE TORQUE APPLIED TO THE INSTRUMENT DURING SCREW TIGHTENING. HOWEVER, NOT ENOUGH INFORMATION WAS PROVIDED IN THE COMPLAINT TO DETERMINE THAT THIS IS THE ROOT CAUSE. THE COMPLAINT WAS DEEMED INDETERMINATE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE TIP OF A SCREWDRIVER BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND A BACK UP SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS ONE OF ONE REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107340 SCREWDRIVER FOR SYNFIX(TM)-LR HXX SYNTHES GMBH 2502352

    Patients

    Seq Age Sex Outcome Treatment
    1