BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POINTED REDUCTION FORCEPS

    MDR report key: 13472351 · Received February 7, 2022

    Report

    Report Number
    1220246-2022-04436
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 19, 2022
    Report Date
    March 1, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317949
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. VISUAL INSPECTION IDENTIFIED THAT ONE OF THE TIPS OF THE FORCES HAD BROKEN OFF. NO DAMAGED OBSERVED TO THE OTHER TIP. DEVICE FUNCTIONING SHOWED DEVICE WORKS AS INTENDED. THE CAUSE OF THIS EVENT IS UNDETERMINED; HOWEVER, THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF USER APPLIED MECHANICAL DAMAGE DURING USE, SUCH AS THROUGH PRYING/LEVERAGING AND/OR TORQUING THE FORCEPS.

    Description of Event or Problem · 0

    ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TIP OF THE AR-18700-45 BONE FORCEPS BROKE OFF WHILE TRYING TO REDUCE A LISFRANC FX, HAVEN¿T BEEN ABLE TO FIND THE TOP OF THE FORCEPS BUT IT¿S NOT IN THE PATIENT. THIS WAS DISCOVERED DURING USE IN PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION 1/25/2022 ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE POINTED REDUCTION CLAMP TIP BROKE OFF OF THE AR-18700-45 BONE FORCEPS WHILE TRYING TO REDUCE A LISFRANC FX. THE CLAMP WAS INSIDE OF THE PATIENT WHEN IT BROKE AND FRAGMENT WAS NOT FOUND. THIS WAS DISCOVERED DURING USE IN A TMT FUSION ON (B)(6) 2022. THE SURGEON USED AN X-RAY HOWEVER, STILL UNABLE TO LOCATE THE BROKEN FRAGMENT. THE CASE WAS COMPLETED BY USING A LOBSTER CLAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986549 POINTED REDUCTION FORCEPS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. POINTED REDUCTION FORCEPS 6671931 00888867317949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown