BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW,TI,3.5MMX 42MM

    MDR report key: 16528642 · Received March 13, 2023

    Report

    Report Number
    1220246-2023-06412
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    February 20, 2023
    Report Date
    May 8, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867050686
    PMA / PMN Number
    K203294
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: B1, B2, B5: COMPLAINT CONFIRMED. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE HEAD HAD BROKEN OFF OF THE BODY OF THE DEVICE. THE OUTER DIAMETER OF THE HEAD WAS MEASURED AND FOUND TO MEET DEVICE SPECIFICATIONS. THE INNER DIAMETER OF THE HEXALOBE WAS ALSO MEASURED AND FOUND TO MEET THE DRAWING SPECIFICATIONS. THE MATERIAL OF THE DEVICE WAS TESTED AS WELL AND FOUND TO MEET THE SPECIFIC COMPOSITION REQUIRED BY THE DRAWING. THE CAUSE OF THESE REMAINS UNDETERMINED.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION IS RECEIVED ON 2/21/2023: THE CASE WAS COMPLETED AFTER ADDING THREE MORE SCREWS TO THE PLATE. THE BROKEN BODY OF THE SCREW WAS LEFT IN PLACE. THE BODY OF THE SCREW HAD NO HEAD, THEREFORE, THERE WAS NO WAY TO REMOVE THE SCREW. THIS WAS DISCOVERED DURING AN ORIF OF A NON-UNION MEDIAL MALLEOLUS FRACTURE. A 6-HOLE 1/3 TUBULAR PLATE WAS USED FROM THE SAME TITANIUM ANKLE FRACTURE SET- THE PLATE WAS NOT CHANGED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-42 LOW PROFILE SCREW BROKE DURING INSERTION, ON THE FINAL TIGHTENING. SURGEON PREDRILLED WITH A 2.5MM DRILL USING A SOFT TISSUE GUIDE AND PLACED THE SCREW FIRST UNDER POWER AND THEN BY HAND WHEN THE HEAD OF THE SCREW BROKE OFF FROM THE SHAFT OF THE SCREW. THE HEAD WAS RETRIEVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514387 LO-PRO SCRW,TI,3.5MMX 42MM SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 42MM 00888867050686

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other