BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 18191048 · Received November 22, 2023

    Report

    Report Number
    1220246-2023-08866
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 24, 2023
    Report Date
    February 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: B5. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON FURTHER REVIEW AND EVALUATION OF ASSOCIATED RISK DOCUMENTATION, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803. CORRECTION: H1: MALFUNCTION TO N/A.

    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. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 1/25/2024: THE ISSUE WITH THE INSTRUMENTS WAS DISCOVERED DURING INSPECTION PRIOR TO THE CASE STARTING. BACK UP SETS WERE USED TO COMPLETE THE CASE.

    Description of Event or Problem · 0

    ON 10/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06066436 THAT ALL THE FOLLOWING REAMERS KEPT BINDING UP AND BENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED ADVERSE EFFECTS ON THE PATIENT. (QTY. 2) AR-9597-10 / ANGLED REAMER SLEEVE, 10° / BATCH: 37621943 . (QTY. 1) AR-9597-20 ANGLED REAMER SLEEVE, 20° / BATCH: 37621942 . (QTY. 1) AR-9597-20 / ANGLED REAMER SLEEVE, 20° / BATCH: 37622131. (QTY. 1) AR-9676 / ANGLED REAMER, DRIVE SHAFT / BATCH: 022004 . (QTY. 1) AR-9676 / ANGLED REAMER, DRIVE SHAFT / BATCH: 022028 . (QTY. 1) AR-9297-15 / AVL ANGLED REAMER SLEEVE ASSEMBLY, 15 / BATCH: 052043. (QTY. 1) AR-9297-25 / AVL ANGLED REAMER SLEEVE ASSEMBLY, 25 / BATCH: 052043.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723416 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 37621943 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown