BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR EXTRACTION SCREWDRIVER

    MDR report key: 4051839 · Received September 2, 2014

    Report

    Report Number
    1719045-2014-10412
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH 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. 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 MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE: TELEFLEX MEDICAL MANUFACTURED THE INNER SHAFT FOR EXTRACTION SCREWDRIVER, P/N 03.613.004, AND LOT NUMBER 6529477 ON PO #1214080 FOR 15 PIECES DELIVERED FEBRUARY 8, 2011. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED FEBRUARY 5, 2011, AND SYNTHES FINAL INSPECTION SHEET # 03IF600033, REVISION ¿G¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON FEBRUARY 14, 2011. DUE TO AN UNKNOWN CAUSE, IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2014 THE INTERNAL THREADING OF THE EXTRACTION SCREWDRIVER BROKE INSIDE A 4. 4.0MM TI CERV SELF-RETAIN SCREW. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONSIDERED CONFIRMED BUT IS NOT MANUFACTURING-RELATED. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS MADE TO THE SYNTHES DRAWING P/N 03.613.004, REVISION ¿C¿, RELEASED ON MARCH 3, 2009. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: TELEFLEX MEDICAL MANUFACTURED THE INNER SHAFT FOR EXTRACTION SCREWDRIVER, P/N 03.613.004, AND LOT #6529477 ON PO #1214080 FOR 15 PIECES DELIVERED FEBRUARY 8, 2011. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED FEBRUARY 5, 2011, AND SYNTHES FINAL INSPECTION SHEET #NS020660, REVISION ¿D¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON FEBRUARY 14, 2011. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS MADE TO THE SYNTHES DRAWING P/N 03.613.004, REVISION ¿C¿, RELEASED ON MARCH 3, 2009. A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES 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. ONE INNER SHAFT 03.613.004 (LOT# 6529477) AND ONE SCREW 04.613.516 (LOT# UNKNOWN) WERE RECEIVED FOR EVALUATION. THE INVOLVED SCREW IS PART OF THE VECTRA SYSTEM AS SUCH, THIS INDICATES THAT A VECTRA SYSTEM WAS BEING USED AND THIS EVALUATION IS FOCUSED ON THIS SYSTEM. UPON EXAMINATION OF THESE RETURNED DEVICES, THE REPORTED CONDITION OF BROKEN TIP WAS CONFIRMED HOWEVER THE REPORTED CONDITION OF DOES NOT FIT WITH OTHER PARTS FOR THE SCREW CANNOT BE CONFIRMED. THE SCREW EXHIBITS ONLY SIGNS OF ANODIZED PURPLE LAYER WORN OUT, MOST LIKELY RESULTED AFTER BEING USED, NO VISIBLE DEFECTS ARE NOTED THAT COULD CONTRIBUTED TO CAUSE AN INTERACTION PROBLEM WITH THE INNER SHAFT. THE DISTAL THREADED TIP OF THE INNER SHAFT WAS RECEIVED FRACTURED OFF WITH APPROXIMATELY 1.25 THREADS REMAINING AND THE LIBERATED PORTION REMAINS INSIDE THE HEAD OF THE RECEIVED SCREW. 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 GUIDE. IN CONCLUSION, THE REPORTED CONDITION OF BROKEN INNER SHAFT TIP WAS CONFIRMED HOWEVER THE REPORTED CONDITION OF DOES NOT FIT WITH OTHER PARTS FOR THE SCREW CANNOT BE 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 THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2014 THE INTERNAL THREADING OF THE EXTRACTION SCREWDRIVER BROKE INSIDE A SCREW. IT WAS ALSO REPORTED THAT DURING THIS PROCEDURE AN MTF BONE SHAFT BROKE WHEN IMPLANTING TO THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORT OF A TIME DELAY NOR PATIENT HARM. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532733 INNER SHAFT FOR EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6529477

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR