BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X25 FINAL TIGHTENER

    MDR report key: 8817866 · Received July 23, 2019

    Report

    Report Number
    1526439-2019-51864
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    April 29, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034199030
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED ON RETURNED TIGHTENER DRIVER¿S DISTAL TIP HAD BECOME STRIPPED. NOTED DAMAGE INDICATED THAT THE STRIPPING OCCURRED IN THE DIRECTION OF TIGHTENING. 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. A DEFINITIVE ROOT CAUSE FOR THE HEXLOBES ON THE FINAL TIGHTENER DRIVER¿S DISTAL TIP BECOMING STRIPPED CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE NOTED DAMAGE SUGGESTS THAT THE FINAL TIGHTENER DRIVER THAT WAS LIKELY SUBJECTED TO UNANTICIPATED TORSIONAL FORCES DURING THE TIGHTENING PROCESS. 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, 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

    IT WAS REPORTED THAT THE ITEM WAS MARKED AS BROKEN IN BIOMED DEPARTMENT, UPON VISUAL INSPECTION THE TIP OF THE DRIVER IS STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609594 X25 FINAL TIGHTENER DRIVER, PROSTHESIS HWR DEPUY SPINE INC GM4065502 10705034199030

    Patients

    Seq Age Sex Outcome Treatment
    1