BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 3906725 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12283
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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. LOT NUMBER REPORTED, NOT FOUND IN JDE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL MANUFACTURE DATES: NOVEMBER 3, 2010 AND NOVEMBER 8, 2010. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: TELEFLEX MEDICAL, INC. MANUFACTURED THE EXTRACTION SCREWDRIVER, PART NUMBER 352.311, AND LOT NUMBER 6434506. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND TO THE SYNTHES FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: ONE INNER SHAFT 03.613.004 (LOT 6434506) AND ONE 4.5MM CANCELLOUS BONE VARIABLE ANGLE SCREW (SELF-TAPING, LOT UNKNOWN) WERE RECEIVED FOR EVALUATION. THE DRIVER 352.311 CONSISTS OF THREE COMPONENTS: DRIVER SHAFT AND HANDLE ASSEMBLY, INNER SHAFT AND AN OUTER SLEEVE. AS THE INNER SHAFT IS ASSEMBLED INTO THE DRIVER 352.311 WHEN USED, THE APPLICABLE TECHNIQUE GUIDES FOR THE DRIVER 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. 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 BLUE 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 GUIDES. THE APPLICABLE INNER SHAFT AND SCREW DRAWINGS WERE REVIEWED. THE DRAWINGS CALL OUT THE APPROPRIATED DIMENSIONS, MATERIAL (STAIN STEEL CUSTOM 465 FOR THE INNER SHAFT) AND FINISHING PROCESSES FOR RESPECTIVE A SUCCESSFUL DEVICE DESIGNS. THE INNER SHAFT MATERIAL WAS PREVIOUSLY CHANGED FOR THE OLD INNER SHAFT, LATER THE NEW SHAFT 03.613.004 WAS WHICH KNOB WAS IMPROVED TO INCLUDE THE LEGEND ¿FULLY TIGHTEN¿. ALSO, TOLERANCES BETWEEN THE SHAFT AND THE SCREW INTERFACE WERE VERIFIED, NO POTENTIAL DESIGN ISSUES BETWEEN THESE DEVICES WERE FOUND. 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. 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 AN INNER SHAFT FOR AN EXTRACTION SCREWDRIVER BECAME STUCK IN THE SCREW INTRAOPERATIVELY. THE SURGEON WAS PUTTING IN A SCREW, USING THE EXTRACTION SCREWDRIVER WHEN THE THREADS ON THE INNER SHAFT SNAPPED OFF INSIDE OF THE SCREW. ANOTHER EXTRACTION SCREWDRIVER AND SCREW WERE AVAILABLE TO REMOVE THE OLD SCREW AND REPLACE IT WITH A NEW ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO TIME DELAY AND NO PATIENT HARM REPORTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383759 EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 6434506

    Patients

    Seq Age Sex Outcome Treatment
    1