BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM PRIMARY REAMER

    MDR report key: 21093396 · Received January 7, 2025

    Report

    Report Number
    1220246-2025-09247
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 10, 2024
    Report Date
    May 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9618-24 24 MM PRIMARY REAMER BATCH NUMBER: 022107 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED WEAR AND TEAR TO THE DEVICE WITH DISCOLORATION AND FADED LASER MARKINGS OBSERVED. IT WAS FURTHER NOTED THAT THE CUTTING EDGES WERE WORN AND WERE NICKED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPETITIVE USE IN THE FIELD. MANUFACTURED DATE: 02-MAR-2021.

    Description of Event or Problem · 0

    ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9618-24 24 MM PRIMARY REAMER AND AN AR-1999HH RATCHETING HANDLE, HYBRID HUDSON WAS WORN. NO ADVERSE EFFECTS ON THE PATIENT REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/16/2024: THIS WAS DISCOVERED IN A REVERSE TSA PROCEDURE ON (B)(6)2024. THEY USED A NEW REAMER AND HANDLE FROM ANOTHER SET TO COMPLETE THE CASE. NO CASE DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105618 24MM PRIMARY REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 24MM PRIMARY REAMER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown