BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRSPR,BLNT 3.4 MMSTR W/NR HNDL

    MDR report key: 11797794 · Received May 10, 2021

    Report

    Report Number
    1220246-2021-03017
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 21, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867006218
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-12500NR, BATCH 40956 GRASPER WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING IDENTIFIED THAT WHEN THE 111-301P FINGER WAS MANIPULATED, THE 113-305 GRASPER JAW WOULD NOT ACTUATE IN RESPONSE. THE OBSERVED CONDITION IS TYPICALLY CAUSED BY APPLYING EXCESSIVE FORCE WHILE GRASPING TISSUE, LEADING TO BREAKAGE OF THE SHEAR PIN.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE AR-12500NR GRASPER IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700006 GRSPR,BLNT 3.4 MMSTR W/NR HNDL ACCESSORIES, ARTHROSCOPIC NBH ARTHREX, INC. GRSPR,BLNT 3.4 MMSTR W/NR HNDL 40956 00888867006218

    Patients

    Seq Age Sex Outcome Treatment
    1