BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION SLEEVE

    MDR report key: 22017963 · Received May 14, 2025

    Report

    Report Number
    1220246-2025-02041
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 17, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036480
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR OF THE DEVICE, AS THE MANUFACTURING DATE IS 2022. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE FAILURE WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025: DURING A TROCHANTERIC NAIL PROCEDURE ON AN UNKNOWN DATE, THE COMPRESSION WHEEL AND INSERTER HANDLE FAILED TO PROVIDE PROPER COMPRESSION, EXHIBITING SLIPPING OR CLICKING AT A CERTAIN POINT WHEN ATTEMPTING TO COMPRESS. THIS ISSUE HAD PREVIOUSLY BEEN OBSERVED IN THREE CASES INVOLVING TROCH NAILS, THOUGH SPECIFIC DATES OR CASE DETAILS ARE UNAVAILABLE. WHILE THE ISSUE DID NOT IMPACT THE CASES OR PATIENTS, A RECURRING PATTERN WAS LATER IDENTIFIED. THE CASE WAS COMPLETED IN STANDARD FASHION, ACHIEVING AS MUCH COMPRESSION AS THE INSTRUMENT ALLOWED WITHOUT REQUIRING ADDITIONAL PRODUCTS. THERE WAS NO REPORTED DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AFFECTED PRODUCTS, IN THIS CASE, INCLUDED THE LAG SCREW INSERTER AND COMPRESSION WHEEL.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN 5031-000 LOCKING TOOL ASSEMBLY GALILEO LAG SCREW AND (QTY. 2) OF AN 5032-000 COMPRESSION SLEEVE, LAG SCREW INSERTER WERE NOT WORKING FOR COMPRESSION DURING THE CASES. THIS OCCURRED ON THREE OCCASIONS, WITH NO PATIENTS AFFECTED BY THE ISSUE. NO FURTHER INFORMATION OR INDIVIDUAL CASE DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING CASES WHERE NO INDIVIDUAL CASE INFORMATION WAS PROVIDED, AND NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089196 COMPRESSION SLEEVE INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. COMPRESSION SLEEVE 212986 00848665036480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown