BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER T25 SELF-RETAINING 245MM

    MDR report key: 3083210 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10557
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    June 4, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. 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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION NOTED THAT THE RED AND ORANGE TAPE WAS ON THE INSTRUMENT SHAFT WHICH WAS NOT RESULTS OF THE MANUFACTURING PROCESS. A GOUGE WAS NOTED ON ONE SIDE OF THE HANDLE UNDER THE PART NUMBER ETCH. THE HANDLE WAS NOT ABLE TO BE ROTATED ABOUT THE SHAFT BY HAND. A BENCH VISE WAS USED TO SECURE THE SHAFT DURING THIS EVALUATION WHICH THEN CONFIRMED THAT THE HANDLE DOES SPIN ABOUT THE SHAFT. THE DOWEL PINS ARE PROTRUDING FROM THE HANDLE BY APPROXIMATELY 1MM ON EACH SIDE OF THE HANDLE. MATERIAL HARDNESS FOR DOWEL PINS WAS NOT MEASURED DURING THIS EVALUATION BECAUSE NO SPECIFICATION EXISTS IN DHR FOR DOWEL PIN HARDNESS. FEATURES RELATED TO THIS COMPLAINT (DOWEL PIN LENGTH, MATERIAL, O.D.) COULD NOT BE VERIFIED DURING THIS EVALUATION BECAUSE BOTH DOWEL PINS REMAIN SECURED IN THE HANDLE PREVENTING EVALUATION. THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO A NON-UNION. PATIENT COMPLAINED OF PAIN FROM WEIGHT BEARING. SURGEON REMOVED ALL HARDWARE AND REVISED PATIENT WITH DBX ALLOGRAFT AND PLATE AND SCREW CONSTRUCT. DURING THE REMOVAL OF HARDWARE, THE SURGEON WAS USING THE STAR/HEXDRIVE SCREWDRIVER TO REMOVE THE SCREW FROM THE PLATE AND THE TIP OF THE SCREWDRIVER BROKE OFF INTO THE SCREW HEAD. THE PIN ON THE HANDLE OF THE STARDRIVE SCREWDRIVER SHEARED OFF FROM THE SHAFT ALLOWING THE SCREWDRIVER HANDLE TO SPIN FREELY. STARDRIVE SCREWDRIVER WAS NOT USED DURING THE PROCEDURE. SURGEON THEN ANOTHER STARDRIVE SCREWDRIVER TO REMOVE THE SCREW AND THE TIP OF THE SCREWDRIVER BECAME TWISTED-BENT. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. REMOVED HARDWARE WAS DISCARDED OF AND IS UNAVAILABLE FOR RETURN. CONSULTANT WILL RETURN THE INSTRUMENTS. THIS IS 2 OF 10 REPORTS FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183671 STARDRIVE SCREWDRIVER T25 SELF-RETAINING 245MM HXX SYNTHES BRANDYWINE 4905143

    Patients

    Seq Age Sex Outcome Treatment
    1