BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X25 FINAL TIGHTENER

    MDR report key: 9036967 · Received September 13, 2019

    Report

    Report Number
    1526439-2019-52078
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034199030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE TIGHTENER¿S DISTAL TIP WAS TWISTED AND WORN. THE TIP WAS TWISTED IN THE DIRECTION OF TIGHTENING. THE TWISTED/WORN CONDITION OF THE TIP WOULD RENDER THE DEVICE INOPERABLE. THERE WERE SURFACE SCRATCHES ALONG THE SHAFT OF THE DEVICE CONSISTENT WITH NORMAL WEAR. IT APPEARS THE SHAFT WAS MARKED WITH A PINK MARKER AS SMALL PINK RESIDUE WAS PRESENT ON THE SHAFT. 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. AFTER VISUAL INSPECTION, IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    DOCTOR HAD AN EXPEDIUM CASE ON AUGUST 22ND WHERE A THORACOLUMBAR SCOLIOSIS FUSION WAS TAKING PLACE AND THE PATIENT HAD VERY HARD BONE. DURING THE FINAL TIGHTENING, THE DOCTOR STRIPPED 4 TORQUE DRIVERS. THE PATIENT WAS NOT AFFECTED BY THIS AND CASE WAS COMPLETED WITHOUT DELAY. NOTHING FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811574 X25 FINAL TIGHTENER DRIVER, PROSTHESIS HWR DEPUY SPINE INC GM4697602 10705034199030

    Patients

    Seq Age Sex Outcome Treatment
    1