BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER STANDARD

    MDR report key: 2982036 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-00655
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE STRAIGHT TIP SCREWDRIVER HAS A FRACTURED TIP WITH APPROXIMATELY 4.5MM FRACTURED AT THE LOWEST POINT. THE DRIVER WAS USED DURING THE REMOVAL OF LOCKING CAPS, HOWEVER, THE TORQUE-LIMITING HANDLE WAS NOT STATED AS BEING USED. THE TORQUE APPLIED MAY HAVE BEEN BEYOND THE STRENGTH OF THE DRIVER WHICH LED TO THE FAILURE. THE APPEARANCE OF THE FRACTURED TIP ON THE RETURNED ITEM MATCHES THE APPEARANCE OF DRIVERS THAT WERE TESTED IN A LABORATORY SETTING AT SYNTHES (MT11-454). IN THE LABORATORY TEST, YIELDING OCCURRED AT APPROXIMATELY 15NM, AND SHEARING OCCURRED AT GREATER THAN OR EQUAL TO 20NM. THIS SUGGESTS THAT THE RETURNED PART WAS SUBJECTED TO TORQUE AS HIGH AS 20NM. THE FACT THAT THE DAMAGE IS ONLY AT THE TIP (0.5MM LENGTH AT WORST CASE) SUGGESTS THAT THE DRIVER WERE NOT FULLY SEATED IN THE LOCKING CAP. THE TORQUE APPLIED ON THE SMALL SURFACE AREA OF THE ENGAGED PORTION OF THE DRIVER TIP CAN LEAD TO MATERIAL SHEARING OFF THE DRIVER TIP. AS THE DRIVER STILL ENGAGES THE DRIVE RECESS OF A MATING SCREW, THE DRIVER WAS MOST LIKELY MIS-ALIGNED WITH THE DRIVE RECESS OF THE SCREW AND NOT PLUNGED TO THE PROPER DEPTH DURING THE CASE. IN ADDITION, IT IS NOT CLEAR AS TO WHETHER OR NOT THE TORQUE-LIMITING HANDLE WAS USED AS STATED ABOVE. THE TECHNIQUE STATES TO USE THE TORQUE-LIMITING HANDLE DURING THE LOOSENING PROCESS OF THE LOCKING CAPS. THE MATERIAL X15-TN STAINLESS STEEL IS AN APPROPRIATE MATERIAL FOR THE DRIVERS AND IT IS USED IN OTHER STANDARD SYNTHES DRIVERS AS WELL. THE COMPLAINT DESCRIPTION DOES NOT STATE WHETHER OR NOT THE TORQUE-LIMITING HANDLE WAS USED DURING THE ATTEMPTED LOOSENING OF THE LOCKING CAPS. BASED ON THE FAILURE MODE OF THE DRIVER, THE HANDLE MOST LIKELY WAS NOT USED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PART RECEIVED FOR DHR REVIEW, THEREFORE DHR REVIEW IS DEEMED TO BE INDETERMINATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. TIP IS BROKEN OFF, FRAGMENTS WERE NOT SENT BACK FOR INVESTIGATION. THE RELEVANT DIMENSION OF THE TIP CAN NOT BE VERIFIED ANYMORE. THE HARDNESS CHECK HAS SHOWN THAT THE HARDNESS IS (B)(4), WHICH IS WITHIN THE SPECIFICATION OF (B)(4). THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH MATRIX FOR LUMBAR FUSION AT L4-L5. ON (B)(6) 2013 PATIENT WAS RETURNED TO OPERATING ROOM TO EXTEND THE LUMBAR FUSION CONSTRUCT TO LEVEL L3-L4 DUE TO ADJACENT LEVEL DISC DISEASE. WHILE REMOVING THE LOCKING CAPS AND RODS AT L4-L5, THE TIP OF THE SCREWDRIVER SHAFT SHEARED OFF. ALL BROKEN FRAGMENTS WERE RETRIEVED, THE SCREWS FOR THE L4-L5 FUSION WERE NOT REMOVED AND REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87710 STRAIGHT TIP T25 DRIVER STANDARD STRAIGHT TIP T25 DRIVER STANDARD HXX SYNTHES GMBH 7614370

    Patients

    Seq Age Sex Outcome Treatment
    1