BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR EXTRACTION

    MDR report key: 3695220 · Received March 24, 2014

    Report

    Report Number
    1719045-2014-10101
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 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

    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

    THE DEVICE HISTORY REVIEW REPORTED TELEFLEX MEDICAL, INC (PRESENTLY TECOMET KENOSHA) MANUFACTURED THE INNER SHAFT FOR EXTRACTION SCREWDRIVER, P/N 03.613.004, LOT # 6818419. THE CERTIFICATE OF COMPLIANCE (DATED DECEMBER 29, 2011) INDICATES THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE SYNTHES DRAWING NUMBER 03.613.004, REVISION ¿C¿. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET # NS020660, REVISION ¿D¿. THERE WERE NO COMPLAINT-RELATED ISSUES, MANUFACTURING REVIEW REPORTS, OR NON-CONFORMANCE REPORTS ASSOCIATED WITH THIS LOT. THE INNER SHAFT WAS MANUFACTURED TO THE SYNTHES DRAWING NUMBER 03.613.004, REVISION ¿C¿. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.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. 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. AS IT WAS REPORTED THAT REPORTED EVENT OCCURRED DURING A VECTRA CASE, THIS EVALUATION IS FOCUSED ON THIS SYSTEM. IT WAS REPORTED THE INNER SHAFT BROKE INTO TWO PIECES; DURING THE PROCEDURE SCREWS WERE BEING IMPLANTED AND THEN ONE OF THEM WAS REMOVED, THE INNER SHAFTS USED BROKE APPARENTLY DURING INSERTION AND REMOVAL. ONLY THREE (3) INNER SHAFTS 03.613.004 WERE RECEIVED FOR EVALUATION; IT IS UNKNOWN IF THEY WERE ORIGINAL PARTS OF SPECIFIC CORRESPONDING DRIVERS 352.311 OR REPLACEMENT PARTS FOR AN EXISTING EXTRACTION DRIVER AT CUSTOMER SITE. AT EVALUATION TIME THE RECEIVED PARTS WERE NOT LOCATED HOWEVER PICTURE EXHIBITING THE REPORTED FAILURE WERE AVAILABLE AS SUCH THIS EVALUATION HAS BEEN CONDUCTED BASED ON AVAILABLE PICTURE (ATTACHED INTO THE COMPLAINT FILE). THE DRIVER 352.311 CONSISTS OF THREE COMPONENTS: DRIVER SHAFT AND HANDLE ASSEMBLY, INNER SHAFT AND AN OUTER SLEEVE. THE REPORTED INNER SHAFT DEVICE 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 GUIDE FOR THE DRIVER (REFERENCE #J8275-C FOR VECTRA) WAS REVIEWED. THE 352.311 EXTRACTION DRIVER IS USED FOR REMOVAL OF THE VECTRA 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. 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 THAT DURING A PROCEDURE UTILIZING VECTRA, THE SURGEON WAS IMPLANTING SCREWS AND THREE INNER SHAFT TIPS AND ONE EXTRACTION SCREWDRIVER TIP BROKE OFF. AFTER FLUOROSCOPY WAS USED, THE SURGEON DECIDED HE DIDN'T LIKE THE TRAJECTORY OF ONE OF THE SCREWS. IN ORDER TO REMOVE THE SCREW, A NEW EXTRACTION SCREWDRIVER WAS NEEDED AND WAS FLASH-STERILIZED. THIS CAUSED LESS THAN A 15 MINUTE DELAY. WHILE THE SURGEON WAS REMOVING THE SCREW, THE INNER SHAFT AND EXTRACTION SCREWDRIVER TIPS BROKE OFF. IT IS UNKNOWN IF THE FRAGMENTS OF ALL SIX PARTS ARE INSIDE THE PATIENT OR WERE DISCARDED. THERE WAS NO REPORTED PATIENT HARM. IT WAS REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS 1 OF 6 REPORTS FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171428 INNER SHAFT FOR EXTRACTION SCREWDRIVERS HXX SYNTHES MONUMENT 6818419

    Patients

    Seq Age Sex Outcome Treatment
    1