BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 11789803 · Received May 7, 2021

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    Report

    Report Number
    11789803
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 19, 2021
    Manufacturer
    PROVISION
    Product Code
    HWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLE MULTI-FIRE SCORPION TIP BROKE OFF DURING SURGERY, THIS IS THE SECOND TIME IT HAS HAPPENED, SURGEON DID DO X-RAYS AT THE END OF THE CASE. PER THE ATTENDING SURGEON'S OPERATING ROOM NOTE: I NOTICED THE TIP OF THE SUTURE PASSER WAS MISSING AND BROKEN OFF. I DID A THOROUGH ARTHROSCOPIC INTRAOPERATIVE EXAMINATION OF THE SHOULDER, AND DID NOT FIND OR SEE IT.   INTRAOPERATIVE AS WELL POSTOPERATIVE X-RAYS WERE OBTAINED, NEITHER OF WHICH REVEALED A FOREIGN BODY. THIS LEADS ME TO BELIEVE THAT THIS BROKE OFF OUTSIDE OF THE SHOULDER, OR WAS REMOVED VIA THE SUCTION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690683 ARTHREX PASSER HWQ PROVISION AR-13995N 12534705

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA