BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC

    MDR report key: 3030074 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01281
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE TORQUE LIMITING HANDLE AND THE T25 STARDRIVE ARE FOUND IN THE PANGEA SYSTEM TECHNIQUE GUIDE. THESE DEVICES ARE USED IN COMBINATION TO PROVIDE A FINAL TIGHTENING OF THE PANGEA LOCKING CAPS TO SECURE THE PEDICLE SCREW CONSTRUCT. PER THE COMPLAINT DESCRIPTION, THE TORQUE LIMITING HANDLE DID NOT LIMIT THE TORQUE ON THE DRIVER. THIS LEADS TO A FRACTURE DUE TO SHEAR FORCES EXCEEDING THE TENSILE STRENGTH OF THE DRIVER. THE REMAINING DRIVER TIP IS SLIGHTLY TWISTED (PLASTICALLY DEFORMED) IN A CLOCKWISE ORIENTATION INDICATING THAT IT FAILED IN TIGHTENING AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THE TORQUE LIMITING HANDLE CANNOT BE EVALUATED AS IT HAD BEEN DISASSEMBLED PRIOR TO THE DESIGN EVALUATION. THE AMOUNT OF TORQUE APPLIED TO THE DRIVER AND CONSTRUCT CANNOT BE DETERMINED. THE CHU ENGINEER CALCULATED A FAILURE TORQUE (FRACTURE) OF 12.57 N-M. THIS SUGGESTS THAT THE DRIVER EXPERIENCED AT LEAST THAT VALUE. THE MATERIALS AND SPECIFICATIONS WERE REVIEWED IN THE DRAWINGS. THERE WAS NO RECORD OF THIS TORQUE LIMITING HANDLE LOT # 566827H06-131 EVER BEING TESTED AFTER THE RECOMMENDED 6MONTHS/50 STERILIZATION CYCLES. REFERENCED FROM THE MANUFACTURING EVALUATION: THE SUPPLIER CONDUCTED A REVIEW OF THE COMPLAINT PRODUCT AND DETERMINED THAT THE SMALLER FRONT GEAR IN THE TORQUE MECHANISMS HAS CRACKED IN BOTH INSTRUMENTS. THE CRACKS ARE ALONG THE PRESSED PINS OF THE GEARS. THE MOST LIKELY CAUSE FOR THE CRACKS IS FROM UNDO STRESS PLACED ON THE GEARS BY EITHER OVER TORQUING OR REVERSE TORQUING THE INSTRUMENTS. THE HAZARD OF THE DRIVER BREAKING DUE TO THE TORQUE LIMITING HANDLE FAILING IS NOT LISTED IN THIS RISK ASSESSMENT. THE FRACTURED GEARS INDICATE THERE WAS OVER STRESS TORQUING OR REVERSE TORQUING. THE TORQUE LIMITING HANDLE FAILING LEAD TO AN OVER TORQUE ON THE DRIVER WHICH WAS ABOVE THE TENSILE STRENGTH OF THE DRIVER. INVESTIGATION IS ON-GOING. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT WAS NOT RETURNED FOR FURTHER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED BECAUSE OF THE DAMAGE AS THE BROKEN FRAGMENTS WERE NOT SENT BACK FOR INVESTIGATION. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. AS INDICATED IN THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL WAS USED AND THE HARDNESS WAS WITHIN THE SPECIFICATIONS. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. IT IS CLEARLY VISIBLE THAT THE TIP WAS TWISTED CLOCKWISE BEFORE IT BROKE, WHICH IS AN INDICATION THAT TOO MUCH TORQUE, POSSIBLY IN COMBINATION WITH HIGH LATERAL STRESS, WAS APPLIED ONTO THIS SCREWDRIVER AND THAT FINALLY A MECHANICAL OVERLOAD CAUSED THE BREAKAGE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED AS TREATMENT AND NOT DIAGNOSIS. DEVICE WAS RECEIVED, INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    POSTERIOR LUMBAR SURGERY, LEVEL L5-S1 WAS PERFORMED ON 3/4/13. DURING THE FINAL TIGHTENING OF THE LOCKING SCREWS, THE TORQUE WRENCH DID NOT CLICK OUT AND WHEN FURTHER FORCED UPON TRYING TO GET IT TO CLICK OUT, THE SCREWDRIVER SHAFT FRACTURED. THE SHAFT BROKE OFF INTO 2 TO 3 PIECES AND ALL PIECES WERE RETRIEVED. THE SURGEON SWITCHED SCREWDRIVER SHAFTS AND COMPLETED THE SURGERY. THE SURGERY WAS PROLONGED APPROXIMATELY 2 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133931 SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC HXX SYNTHES GMBH 1658571

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR