BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 18935978 · Received March 19, 2024

    Report

    Report Number
    1220246-2024-01558
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    March 5, 2024
    Report Date
    December 2, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-9597-20 ANGLED REAMER SLEEVE BATCH NUMBER: 37622247 WAS RECEIVED FOR INVESTIGATION. THE MATING PART AR-9676 ANGLED REAMER DRIVESHAFT BATCH NUMBER: 022339 WAS RECEIVED SEPARATELY FROM THE ANGLED REAMER SLEEVE. UPON VISUAL INVESTIGATION, IT WAS NOTED THAT THE AR-9597-20 HAD STRIATIONS ALONG THE COLLAR. A MOST LIKELY CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED OVER REPEATED USAGE. FUNCTIONAL TESTING WAS PERFORMED WITH THE AR-9676 BATCH NUMBER: 022339 AND IT WAS NOTED THAT THE MATING PART WAS ABLE TO ATTACH AND DETACH FROM THE AR-9597-20 ANGLED REAMER SLEEVE EASILY. NO PROBLEM FOUND. REFER TO INVESTIGATION PHOTOS. COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 REAMER SLEEVE AND AR-9676 REAMER SHAFT ARE STUCK. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589326 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 37622247 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown