BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX SHAFT, 2.5MM

    MDR report key: 6725493 · Received July 19, 2017

    Report

    Report Number
    1526439-2017-10585
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 26, 2017
    Manufacturer
    DEPUY-SYNTHES SPINE
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) LOT UNKNOWN. A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE 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

    MEDWATCH REPORT RECEIVED FROM FDA REPORT# MW 5070501. "JOHNSON AND JOHNSON REPRESENTATIVE BROUGHT IN LOANER DEPUY INSTRUMENT TO ASSIST IN REMOVING OLD SYSTEM. DURING POSTERIOR SPINAL FUSION HARDWARE REMOVAL, THE TIP OF THE SCREWDRIVER BROKE WITHIN THE TULIP OF THE S1 SCREW. THE FRACTURED TIP OF THE SCREWDRIVER COULD NOT BE REMOVED AND WAS LEFT IN PLACE. BROKEN SCREWDRIVER TIP CONSIDERED A RETAINED FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505808 HEX SHAFT, 2.5MM DRIVER, PROSTHESIS HWR DEPUY-SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1