BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP

    MDR report key: 8734556 · Received June 26, 2019

    Report

    Report Number
    1220246-2019-01162
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867288324
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE SURGEON WAS INSERTING THE TITANIUM 3.5 CORTICAL LOW PROFILE SCREW, AR-8735-16, THROUGH THE COMPRESSION SLOT OF A 6-HOLE TITANIUM RECONSTRUCTION PLATE. AS HE REACHED THE FAR CORTEX, HE CONTINUED TO TRY AND GAIN ADDITIONAL COMPRESSION WHEN THE HEAD OF THE SCREW BROKE FROM THE SHAFT OF THE SCREW. THE HEAD OF THE SCREW WAS RETRIEVED BUT THE SCREW IS STILL IN THE PATIENT STUCK WITHIN THE CORTICES OF BONE. PATIENT IS A MALE, (B)(6). ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 6/6/2019: THIS OCCURRED DURING A RADIAL SHAFT FRACTURE AND THE HEAD OF THE SCREW WAS REMOVED IN DEFAULT OF COMPRESSING THE PLATE TO BONE. THE PATIENT WAS (B)(6) WITH CONSEQUENTIALLY STRONG CORTICAL BONE IN THE RADIUS. REP DOES NOT HAVE X-RAYS BUT THE SCREW SHAFT WAS LEFT IN THE PROXIMAL ASPECT OF THE OBLONG SLOT OF A 6-HOLE TITANIUM RECONSTRUCTION PLATE. NO GRAFT WAS BEING USED IN THIS PLATING CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527839 LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP SCREW, FIXATION, BONE HWC ARTHREX, INC. LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP 2658231 00888867288324

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other