BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-LONG

    MDR report key: 3081803 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10981
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 SUPPLIER'S CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. THE VISUAL INSPECTION PERFORMED AS PART OF THE MANUFACTURING EVALUATION REVEALED THE STARDRIVE SCREWDRIVER WAS RETURNED WITH THE STARDRIVE FORM ROUNDED AT THE EDGES AND TWISTED. THE SHAFT HAS SCRATCHES INDICATING USE. THE MEASURABLE DIMENSIONS AND MATERIAL PROPERTIES ARE WITHIN PRINT SPECIFICATION. FOLLOWING THE PRODUCT EVALUATION AND CONFIRMED THROUGH THE COMPLAINT DESCRIPTION, IT WAS DETERMINED THAT THE SURGEON ATTEMPTED TO LOOSEN USING THE LONG FIXED SPORTS GRIP HANDLE. THIS ALLOWED AN APPLICATION OF TORQUE WELL OVER THE RECOMMENDED LIMIT CAUSING THE DRIVER TO SHATTER. EXTENSIVE BENCH TESTING SUPPORTS THIS THEORY. THE MATRIX TECHNIQUE GUIDE AS WELL AS OTHER PRODUCT SUPPORT INFORMATION FULLY ILLUSTRATES THE PROPER METHOD OF TIGHTENING AND LOOSENING A MATRIX LOCKING CAP USING A 10 NM TORQUE LIMITING HANDLE. IN ORDER TO CAUSE A DRIVER TO FRACTURE, TORQUES IN EXCESS OF 15 NM MUST HAVE BEEN APPLIED. SINCE THIS IS IMPOSSIBLE TO ACHIEVE WITH A MATRIX 10 NM TORQUE LIMITING HANDLE AND THE DAMAGE OCCURRED DURING MANIPULATION OF A LOCKING CAP, THE DAMAGED INSTRUMENT MUST HAVE BEEN UTILIZED IN A MANNER INCONSISTENT WITH THE RECOMMENDED TECHNIQUE. THIS WAS CONFIRMED WITH IDENTIFICATION OF THE RETURNED DEVICE, AND THEREFORE THIS EVENT IS DETERMINED TO BE INVALID. PLACEHOLDER.

    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)(4)

    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. ORIGINAL AWARENESS DATE IS 1/6/2012.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A MATRIX CONSTRUCT ON (B)(6) 2012. POST OPERATIVE X-RAY SHOWED ONE SCREW WAS NOT IN PROPER PLACEMENT. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012. THE SCREW WAS REMOVED AND REPLACED WITH A HOOK. DURING THE REMOVAL THE TIP OF THE SPORT GRIP STARDRIVE SHAFT FOR MATRIX BROKE WHILE TAKING OUT THE LOCKING CAP. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185903 SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-LONG HXX SYNTHES MONUMENT 6612210

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR