BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    MDR report key: 3761280 · Received April 21, 2014

    Report

    Report Number
    1719045-2014-00137
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    January 20, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS FOR P/N 03.632.002, LOT 6968776, SHOWED NO NON-CONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE RAW MATERIAL DHR FOR P/N 11156, LOT 5186613, SHOWED A REWORK ASSOCIATED WITH CAPA 2060. THE REWORK ADDED A MARK TO THE BAR STOCK TO INDICATE ALLOY TYPE AND LOT NUMBER TO ENSURE USE OF CORRECT ALLOY FOR PRODUCT. THE BARS PASSED INSPECTION USING XRFA ANALYSIS TO CONFIRM ALLOY TYPE. THIS REWORK IS NOT RELEVANT TO THE COMPLAINT CONDITION AS THE BAR MARK IS ON THE END OF THE BAR STOCK. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS COMPLETED: THE SCREWDRIVER SHAFT, P/N 03.632.002, LOT 6968776, WAS RECEIVED WITH DAMAGE TO THE STARDRIVE TIP. ONE LOBE OF THE TIP HAS A PORTION BROKEN OFF APPROXIMATELY 1.5MM IN LENGTH. ADDITIONALLY THREE OTHER LOBES HAVE WEAR ON THE TIPS. THE REMAINDER OF THE PART APPEARS TO BE IN GOOD CONDITION. THERE ARE A FEW VERY SLIGHT SURFACE FINISH MARKS ALSO. THE STARDRIVE TAPER DEPTH FAILED DUE TO THE DAMAGE TO THE TIP OF THE PART. THIS MANUFACTURING EVALUATION IS DEEMED INDETERMINATE AS THE STARDRIVE TAPER DEPTH CANNOT BE VERIFIED WITHIN SPECIFICATION DUE TO THE DAMAGE. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: A ONE T25 STAR-DRIVE SHAFT 03.632.002 WAS RECEIVED. THIS INSTRUMENT IS PART OF THE MATRIX (DEFORMITY/DEGENERATIVE) SPINE SYSTEM. THE APPLICABLE TECHNIQUE GUIDES AND RELATED LITERATURE) WERE REVIEWED. THE MATRIX SPINE SYSTEM INCLUDES SEVERAL ALTERNATIVE MATRIX T25 DRIVERS BESIDES THE DEVICE REPORTED. THE SURGEON USES A T25/6 MM HEX COUPLING DRIVER (RECEIVED DRIVER) FOR SCREW INSERTION, FINAL TIGHTENING AND REMOVAL OF THE MATRIX LOCKING CAPS. THESE TECHNIQUE GUIDES INCLUDED CAUTIONS AND RECOMMENDATIONS ASSOCIATED WITH TIGHTENING, LOOSENING OR REMOVING LOCKING CAPS (¿NEVER USE A FIXED OR RATCHETING T-HANDLE SCREWDRIVER FOR THIS TECHNIQUE. IF THE TORQUE LIMITING ATTACHMENT IS NOT USED, BREAKAGE OF THE DRIVER MAY OCCUR AND COULD POTENTIALLY HARM THE PATIENT.¿). THE RECEIVED DRIVER SHOW DISTAL TIP DAMAGED. THE TIP IS WORN OUT, ONE LOBE IS CHIPPED. IT IS LIKELY THAT AN OFF AXIS LOADING CONTRIBUTED TO THE FAILURE OF THIS DRIVER. ALSO NOT USING A LIMITING TORQUE HANDLE OR ONE OUT OF SPECIFICATION MAY ALLOW TO APPLY ENOUGH TORQUE WHICH CAN CONTRIBUTE TO THE FAILURE SEEN HOWEVER THIS IT IS NOT CLEAR HOW THIS DIVER HAS BEEN USED. A REVIEW OF THE APPLICABLE TABULATED DRIVER DRAWING WAS PERFORMED. THIS DRAWING CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL DEVICE DESIGN. THE DEVICE WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE. PRODUCT IS AN INSTRUMENT AND NOT IMPLANTED/EXPLANTED. DEVICE USED FOR TREATMENT NOT DIAGNOSIS. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER IS STRIPPED. IT HAS BEEN USED IN MULTIPLE PROCEDURES BUT THE DAMAGE WAS NOT ASSOCIATED WITH ANY PARTICULAR PROCEDURE. THERE WAS NO EVENT WITH PATIENT INVOLVEMENT. ONE LOBE OF THE TIP HAS A PORTION BROKEN OFF APPROXIMATELY 1.5MM IN LENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239875 T25 STARDRIVE SHAFT F/MATRIX STANDARD HXX SYNTHES MONUMENT 6968776

    Patients

    Seq Age Sex Outcome Treatment
    1