BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE, AVN

    MDR report key: 15183150 · Received August 8, 2022

    Report

    Report Number
    1220246-2022-05339
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    March 4, 2022
    Report Date
    August 8, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867253230
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED. ONE UNPACKED AR-3515H WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE DISTAL END OF THE C8967-01 TUBE WAS BOTH DENTED AND BROKEN. THE WIDTH OF THE TUBE WAS ASSESSED USING DIGITAL MICROMETER ID: 224 AND WAS IDENTIFIED TO MEET DESIGN SPECIFICATIONS. DUE TO EXTENT OF THE DAMAGE PRESENT, THE ID AND OD OF THE BREAKAGE SITE COULD NOT BE ASSESSED. THE CAUSE REMAINS UNDETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3515H DRILL SLEEVE HAD AN ISSUE, THE TIP OF THE SHEATH BENT WHENEVER IT TOUCHED THE BONE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252763 DRILL SLEEVE, AVN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRILL SLEEVE, AVN 051643 00888867253230

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown