BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBSTER CLAMP, RADIOLUCENT

    MDR report key: 14976691 · Received July 11, 2022

    Report

    Report Number
    1220246-2022-05206
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 10, 2022
    Report Date
    July 11, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317987
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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

    ON (B)(4) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49 LOBSTER CLAMP, RADIOLUCENT HAD AN ISSUE. USING THE MINI CFS SET FOR A 5TH MET PROCEDURE ON (B)(6) 2022, THE SURGEON ASKED FOR THE AR-18700-49 LOBSTER CLAMP AND STARTED APPLYING PRESSURE TO CLAMP THE BONE, AND ONE SIDE OF THE CLAMP BROKE OFF. THE PIECE WAS RETRIEVED FROM THE PATIENT. THE REP OBSERVED THE SURGEON PERFORMING THE PROCEDURE AND HE SAID THAT HE WAS NOT APPLYING EXCESSIVE FORCE TO THE CLAMP. AN ALTERNATE CLAMP FROM THE SET WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PIECE THAT BROKE OFF WAS DISCARDED BY THE HOSPITAL, THE OTHER PIECE WAS AVAILABLE FOR RETURN. IT LOOKED LIKE THE ITEM FELL APART AND DID NOT BREAK DUE TO NEGLECT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914136 LOBSTER CLAMP, RADIOLUCENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. LOBSTER CLAMP, RADIOLUCENT 34802042 00888867317987

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown