BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX. CLIP-ON REDUCTION X25 INSERTER

    MDR report key: 4869553 · Received June 25, 2015

    Report

    Report Number
    1526439-2015-10590
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Report Date
    April 22, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    02 DEC 2015 MS: ON INITIAL MW-240709 IS INCORRECT AND SHOULD BE JUN 19, 2015 DATE FUNCTIONAL TEST PERFORMED. (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

    THE APPROXIMATOR FC INSERTER (PRODUCT CODE: 2797-12-590, LOT NUMBER: 0207NT) WAS RETURNED TO THE COMPLAINT HANDLING UNIT (CHU) FOR EVALUATION. THE INITIAL VISUAL INSPECTION OF THE INSERTER DID NOT FIND ANY ISSUES. HOWEVER, THE TIP OF THE INSTRUMENT CAME OFF LATER DURING MECHANICAL TESTING AFTER INSERTING ITS TIP INTO THE DRIVE FEATURE OF A SPARE 1797-02-000 SET SCREW. THE TIP OF THE INSTRUMENT FELL OFF WHEN ATTEMPTING TO RELEASE THE SET SCREW. THE TIP HAD BEEN RETAINED IN THE INSTRUMENT UNTIL THAT POINT. VISUALLY INSPECTING THE TIP AND SHAFT OF THE INSTRUMENT FOUND THAT THE WELD HOLDING THE TWO TOGETHER HAD FAILED. THE BROKEN WELD AND THE FEEDBACK STATING THAT THIS BREAKAGE OCCURRED INTRA-OPERATIVELY MEAN IT MAY HAVE HAD A HIGH AMOUNT OF TORSION APPLIED TO THE DRIVER TIP DURING USE, LEADING TO A SHEAR TORSIONAL FAILURE. IT HAS ALSO BEEN NOTED THAT THE ADVANCED AGE OF THE INSTRUMENT (>8 YEARS) MAY HAVE ALSO CONTRIBUTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE FOR THE DRIVER TIP BREAKAGE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE IS A COMBINATION OF THE UNEXPECTEDLY HIGH TORSIONAL FORCES PLACED ON THE DRIVER TIP IN CONJUNCTION WITH ITS ADVANCED AGE, WHICH MAY HAVE LED TO A SHEAR TORSIONAL FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    X20 STRIPPED AND X25 TIP FELL OFF. BOTH OCCURRED INTRA-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412217 FLEX. CLIP-ON REDUCTION X25 INSERTER DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE 0207NT

    Patients

    Seq Age Sex Outcome Treatment
    1