BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3080361 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10534
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    January 31, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. ORIGINAL AWARENESS DATE: (B)(4) 2012. NO EXPLANT DATE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: VISUAL INSPECTION - THE HANDLE CAN BE ROTATED ABOUT THE SCREWDRIVER SHAFT AND THE DOWEL PIN THAT SECURES THE HANDLE TO THE SHAFT HAS SHEARED IN HALF, WITH A PORTION REMAINING LODGED IN THE SHAFT AND A PORTION LODGED IN THE HANDLE WITH APPROXIMATELY 1 MM PROTRUDING FROM THE HANDLE. MANUFACTURING RECORD REVIEW: ALL FEATURES RELATED TO THIS COMPLAINT, THE DOWEL PIN LENGTH, THE DOWEL PIN COMPONENT MATERIAL AND OUTER DIAMETER, COULD NOT BE VERIFIED DURING THIS EVALUATION DUE TO THE DAMAGED STATE OF THE DEVICE UPON RECEIPT AND ACCURATE MEASUREMENTS TO VERIFY THE DEVICE MATERIAL WERE NOT POSSIBLE. COMPLAINT HISTORY ANALYSIS: NO PREVIOUS RECORDS FOR THIS PART NUMBER ASSOCIATED WITH THIS ISSUE. RISK ASSESSMENT: NO ADVERSE CONSEQUENCES WERE REPORTED AND ALL THE BROKEN PIECES WERE RETRIEVED. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE USING AN ALTERNATE DEVICE AND USED THE ROD HOLDER TO BACK OUT THE SCREW. CONCLUSION: AS ALL MANUFACTURING FEATURES RELATED TO THIS COMPLAINT COULD NOT BE VERIFIED DURING THIS EVALUATION, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 30 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A UNIVERSAL SPINE SYSTEM, USS SYSTEM, AT L4-S1 ON AN UNKNOWN DATE. PATIENT RETURNED TO OR FOR REVISION SURGERY AND REMOVAL OF HARDWARE ON (B)(6) 2012. THE PATIENT DEVELOPED ADJACENT LEVEL DISEASE AT L2-L3, L3-L4 AND PATIENT HAD A SOLID FUSION FROM L4-S1. SURGEON REMOVED ALL THE HARDWARE, 6 SCREWS, 6 NUTS, 6 COLLETS, AND 2 RODS AND THE PATIENT WAS REVISED WITH A NEW USS DUAL-OPENING SYSTEM AT L2-S1. DURING THE REVISION SURGERY, THE HOOK/SCREW HOLDER BROKE DUE TO TOO MUCH TORQUE. SURGEON THEN USED ANOTHER SCREWDRIVER TO SEAT THE SCREW AND THIS SCREWDRIVER BROKE AT THE HANDLE. THE SCREWDRIVER JUST KEPT SPINNING. SURGEON THEN TRIED TO PLACE A SHORT ROD TO BACK OUT THE SCREW. SURGEON GOT THE COLLARS TO ENGAGE WITH SCREW, HOWEVER, THE NUT OF THE COLLARS, WOULD NOT ENGAGE WITH THE DUAL-OPENING SCREW AND THE SURGEON USED A ROD HOLDER TO BACK OUT THE SCREW. THE SURGEON WAS ABLE TO REPLACE AND SEAT THE SCREW. DURING THE ADJUSTMENT OF THE SCREW, THE OTHER HOOK/SCREW HOLDER BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO PATIENT. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE REMOVED IMPLANTS ARE BEING RETURNED TO THE PATIENT AND ARE UNAVAILABLE FOR RETURN. THE PART NUMBERS AND LOT NUMBERS FOR THE REMOVED HARDWARE ARE UNOBTAINABLE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 22 OF 23 REPORTS TO DATE FOR (B)(4) AND IS THE REPORT FOR THE SCREWDRIVER THAT BROKE AT THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183168 4.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 4884725

    Patients

    Seq Age Sex Outcome Treatment
    1