BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 3687705 · Received March 19, 2014

    Report

    Report Number
    1719045-2014-10085
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: TELEFLEX, PRESENTLY TECOMET KENOSHA MANUFACTURED THE EXTRACTION SCREWDRIVER, P/N 352.311, REV. ¿G¿, FOR LOT NUMBERS 6340043, 6340044, 6340045, AND 6342930 (SUPPLIER LOT # 615755A10). LOT # 6340043: PO# 1081001, DATED (B)(4) 2010, FOR (B)(4) PARTS. THE LOT WAS MANUFACTURED AND CONFORMED AS NOTED IN THE TELEFLEX CERTIFICATE OF COMPLIANCE (C OF C), DATED (B)(4) 2010. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2010. LOT # 6340044: PO # 1090979, DATED (B)(4) 2010, FOR (B)(4) PARTS. THE LOT WAS MANUFACTURED AND CONFORMED AS NOTED IN THE TELEFLEX C OF C, DATED (B)(4) 2010. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2010. LOT # 6340045: PO# 1081005, DATED (B)(4) 2010, FOR (B)(4) PARTS. THE LOT WAS MANUFACTURED AND CONFORMED AS NOTED IN THE TELEFLEX C OF C, DATED (B)(4) 2010. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2010. LOT # 6342930: PO# 1090979, DATED (B)(4) 2010, FOR (B)(4) PART. THE LOT WAS MANUFACTURED AND CONFORMED AS NOTED IN THE TELEFLEX C OF C, DATED (B)(4) 2010. ONE PART WAS RELEASED TO THE WAREHOUSE ON (B)(4) 2010. ALL LOTS WERE INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION "N", AND THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES FOR THESE LOTS. THE EXTRACTION SCREWDRIVER WAS MADE TO THE SYNTHES SOURCE CONTROL DRAWING, P/N 352.311, REVISION "G", RELEASED ON (B)(4) 2009. DEVICE IS AN INSTRUMENT AND NOT IMPLANTED/EXPLANTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. PER AS RECEIVED CONDITION OF THE DEVICE; THE DRIVER SHAFT TIP WAS FOUND TO BE FRACTURED ACROSS ALL FOUR DRIVER LOBES. THE LIBERATED PIECES WERE NOT RECEIVED. THE INNER SHAFT WAS NOT RECEIVED AND THE OUTER SLEEVE SHOWS SCRATCHES AND DISCOLORATION OF THE MATERIAL SURFACE. THE APPLICABLE VECTRA TECHNIQUE GUIDE OF INSTRUMENTS AND IMPLANTS FOR ANTERIOR CERVICAL PLATING FOR SPINAL FUSION WAS REVIEWED. THE REPORTED INSTRUMENT 352.311 CONSISTS OF THREE COMPONENTS: DRIVER SHAFT AND HANDLE ASSEMBLY, INNER SHAFT AND AN OUTER SLEEVE. THIS IS AN INSTRUMENT INTENDED TO BE USED FOR REMOVAL OF SCREWS FROM EXISTING IMPLANTS ONLY. IT IS ALSO INDICATED TO USE INSTRUMENT 324.105 FOR SCREW INSERTION. PROPER INSTRUCTIONS AND CAUTION NOTES OF POTENTIAL BREAKAGE IF NOT USED CORRECTLY ARE INCLUDED. THIS DEVICE 352.311 IS ALSO USED TO REMOVE SCREWS OF THE ANTERIOR CERVICAL COMPRESSION SYSTEM (ACCS). UPON INSPECTION OF RETURNED EXTRACTION SCREW DRIVER 352.311, THE REPORTED CONDITION OF SCREWDRIVER TIP BROKEN WAS CONFIRMED. THE DRIVER SHAFT TIP WAS FOUND TO BE FRACTURED ACROSS ALL FOUR DRIVER LOBES. THE LIBERATED PIECES WERE NOT RECEIVED. THE INNER SHAFT WAS NOT RECEIVED AND THE OUTER SLEEVE SHOWS SCRATCHES AND DISCOLORATION OF THE MATERIAL SURFACE. AN OFF AXIS LOADING CONDITION CAN CONTRIBUTE TO CAUSE THE FRACTURES SEEN AND ALSO THE FORCE APPLIED COULD EXCEED THE TENSILE STRENGTH OF THE TIP. HOWEVER, IT IS UNKNOWN IF THESE CONDITIONS WERE PRESENT WHEN INSTRUMENT WAS BEING USED. THE APPLICABLE AND RELATED COMPONENT DRAWINGS WERE REVIEWED. THE DRAWINGS CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL DEVICE DESIGN. THE TORQUE REQUIRED TO FRACTURE (ALL FOUR LOBES) A NOMINAL DRIVER SHAFT IN SHEAR HAS BEEN CALCULATED BEING 6.2 NM. THIS INSTRUMENT WAS FOUND TO BE TO BE ADEQUATE FOR ITS INTENDED USE AS IT IS ROBUST TO REMOVE CERVICAL SCREWS. THE GLOBAL COMPLAINT HISTORY FROM JANUARY 2006 TO APRIL 2014 WAS REVIEWED FOR THIS INSTRUMENT. IN CONCLUSION, THE REPORTED COMPLAINT CONDITION WAS CONFIRMED HOWEVER THE DEVICE DESIGN WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXTRACTION SCREWDRIVER BROKE DURING REVISION SURGERY ON (B)(6) 2014. THE PATIENT WAS ORIGINALLY TREATED FROM C3-C6 WITH A VECTRA 3-LEVEL PLATE AND EIGHT 14 MM SELF-DRILLING SCREWS ON AN UNKNOWN DATE. THE SURGEON DECIDED TO REMOVE THE EXISTING HARDWARE AND ADD HARDWARE TO ANOTHER LEVEL (AT C7) AND CHECK FOR PSEUDARTHROSIS FOR AN UNKNOWN REASON. AS THE SURGEON WAS REMOVING THE LAST SCREW, THE SCREWDRIVER SHEARED AND THREE FRAGMENTS FELL INTO THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND THERE WAS NO ADVERSE EVENT TO THE PATIENT. NO PIECE OF THE SCREWDRIVER REMAINED IN THE PATIENT. THE FRAGMENTS WERE REMOVED EASILY WITH NO ADDITIONAL MEDICAL INTERVENTION; THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO ISSUE WITH THE PLATE OR SCREWS THAT WERE EXPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164448 EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 615755A10

    Patients

    Seq Age Sex Outcome Treatment
    1