BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION SLEEVE

    MDR report key: 19567592 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06117
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    October 22, 2021
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036480
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED 5032-000 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION CONCLUDED WITHOUT OBSERVANCE OF BREAKAGE TO THE O-RING. THE DEVICE WAS COMPARED TO A TEST SAMPLE, WITH NO DIFFERENCES NOTED IN THE CONDITION OF THE O-RING COMPONENTS. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 10/25/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 5032-000 COMPRESSION SLEEVE'S RUBBER "O" RING MADE ITS WAY OUT WHEN THE "LEFTY" LAG SCREW WAS INSERTED. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2021. SURGEON WAS ABLE TO COMPLETE PROCEDURE WITHOUT THE "O" RING AND ASSURED THE LAG SCREW WAS INSERTED WITH GREAT COMPRESSION FUNCTION. DURING INSPECTION OF THE COMPRESSION SLEEVE AFTER THE CASE, IT WAS DETERMINE THAT THE "O" RING APPEARED TO BE CUT IN TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678840 COMPRESSION SLEEVE ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. COMPRESSION SLEEVE 212020 00848665036480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown