BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR EXTRACTION SCREWDRIVER

    MDR report key: 3831863 · Received May 27, 2014

    Report

    Report Number
    1719045-2014-10225
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE LOT WAS INSPECTED AND CONFORMED TO SYNTHES INCOMING FINAL INSPECTION SHEET, NO MRRS OR NCRS WERE GENERATED FOR THIS LOT. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS(B)(4). 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

    (B)(4): A MANUFACTURING EVALUATION WAS COMPLETED: TELEFLEX MEDICAL (PRESENTLY TECOMET ¿ TELEFLEX) MANUFACTURED THE INNER SHAFT FOR EXTRACTION SCREWDRIVER, PART NUMBER 03.613.004, LOT 6818419. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP BROKE; IT WAS NOT RETURNED. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF AND WAS INSPECTED / CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS NOT MANUFACTURING-RELATED AND IS CONSIDERED UNCONFIRMED. ALL MEASURABLE DIMENSIONS WERE CHECKED AND PASSED. THE INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS MADE TO THE RELEVANT SYNTHES DRAWING. DATE ON INITIAL REPORT WAS INCORRECT. DATE SHOULD HAVE BEEN APRIL 29, 2014. 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

    A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE AFFECTED INNER SHAFT ITEM #03.613.004 IS USED ALONG WITH THE EXTRACTION DRIVER ITEM #352.311, BOTH USED TOGETHER FOR REMOVAL OF EXISTING VECTRA AND ACCS IMPLANT SCREWS, HOWEVER IT WAS REPORTED THAT THE TIP BROKE OFF DURING SCREW INSERTION OF AN ACDF PROCEDURE. ONLY ONE INNER SHAFT 03.613.004 (LOT# 6818419) WAS RECEIVED FOR EVALUATION. THE INVOLVED SCREW ITEM NUMBER WAS NOT ORIGINALLY REPORTED OR RETURNED. THE DRIVER 352.311 CONSISTS OF THREE COMPONENTS: DRIVER SHAFT AND HANDLE ASSEMBLY, INNER SHAFT AND AN OUTER SLEEVE. THE REPORTED INNER SHAFT WAS MADE DIMENSIONALLY IDENTICAL TO OLD INNER SHAFT OF 352.311 HOWEVER THE KNOB OF NEW ONE INCLUDES THE LEGEND ¿FULLY TIGHTEN¿. AS THE INNER SHAFT IS ASSEMBLED INTO THE DRIVER 352.311 WHEN USED, THE APPLICABLE TECHNIQUE GUIDES FOR THE DRIVER (REFERENCE #J8275-C FOR VECTRA AND REFERENCE #J5167-A FOR ACCS) WERE REVIEWED. THE 352.311 EXTRACTION DRIVER IS USED FOR REMOVAL OF THE VECTRA AND ACCS SCREWS. THE INNER SHAFT THREADS INTO THE INNER THREAD OF THE SCREW. THE OUTER DRIVER SHAFT IS THEN USED TO UNSCREW THE SCREW FROM THE BONE. 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. UPON EXAMINATION OF THE RETURNED DEVICE, THE REPORTED CONDITION OF BROKEN TIP WAS CONFIRMED. THE DISTAL THREADED TIP OF THE INNER SHAFT WAS RECEIVED FRACTURED OFF WITH APPROXIMATELY 1 THREAD REMAINING AND THE LIBERATED PORTION WAS NOT RECEIVED. THE THREAD FAILURE APPEARS TO HAVE OCCURRED FROM APPLYING A BENDING MOMENT (FORCE APPLIED PERPENDICULAR TO THE AXIS OF THE INSTRUMENT) WHEN THE FORCE EXCEEDED THE TENSILE STRENGTH OF THE THREADED REGION OF THE SHAFT. THE THREADED SHAFT MAY NOT HAVE BEEN FULLY TIGHTENED DOWN TO THE SCREW AS DESCRIBED IN THE TECHNIQUE GUIDES. THE APPLICABLE INNER SHAFT DRAWINGS (SHAFT: 03_613_004 REV. C) WAS REVIEWED. THE DRAWINGS CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL (STAIN STEEL CUSTOM 465 FOR THE INNER SHAFT) AND FINISHING PROCESSES FOR A SUCCESSFUL DEVICE DESIGN. THE INNER SHAFT AND SCREWS ARE ADEQUATE FOR THEIR INTENDED USE (WHEN 03.613.004 IS PROPERLY USED TO ONLY REMOVE CERVICAL SCREWS) AND DID NOT CONTRIBUTE TO CAUSE THIS COMPLAINT. THE GLOBAL COMPLAINT HISTORY FROM JANUARY 2008 TO AUGUST 2014 WAS REVIEWED FOR THIS DEVICE. IN CONCLUSION, THE REPORTED CONDITION OF BROKEN INNER SHAFT TIP WAS CONFIRMED. IT IS NOT CONCLUSIVE HOW THE CONFIRMED FAILURE OCCURRED HOWEVER THE CURRENT DEVICE DESIGN WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE AND THE OCCURRENCE RATE OF THIS FAILURE HAS BEEN REDUCED USING THE NEW INNER SHAFT 03.613.004 VERSUS USING THE OLD INNER SHAFT OF 352.311. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF), THE SURGEON WAS USING A REMOVAL DRIVER TO PLACE THE SCREWS. DURING INSERTION, THE TIP OF THE REMOVAL DRIVER BROKE OFF. NO DELAYS DURING SURGERY OR FRAGMENTS BEING PRODUCED WERE REPORTED. THE TIP OF THE REMOVAL DRIVER REMAINS IN THE PATIENT. NO ADVERSE EVENTS REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311642 INNER SHAFT FOR EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6818419

    Patients

    Seq Age Sex Outcome Treatment
    1