BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII DSH ART TRL 1-2 9MM

    MDR report key: 10496893 · Received September 4, 2020

    Report

    Report Number
    1020279-2020-04400
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 12, 2020
    Report Date
    October 11, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010481344
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS MULTIPLE SCRATCHES, BURRS AND DEEP GOUGES IN THE PLASTIC. THERE ARE A FEW PIECES OF THE DEVICE MISSING AND THESE PIECES WERE NOT RETURNED WITH THE DEVICE. THIS DEVICE SHOWS SIGNIFICANT SIGNS OF WEAR/ USAGE. THIS INSTRUMENT WAS MANUFACTURED IN 2011. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES AND CLEANING CYCLES. AS PLASTICS ARE VULNERABLE AND CRACK MAY HAVE INITIATED DURING USE AND POSSIBLE CAUSES COULD BE DUE TO THE HEATING AND COOLING ASSOCIATED WITH AUTOCLAVING OR PROLONGED USE. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TRIAL WAS BROKE OUTSIDE THE PATIENT AND ALL PIECE WERE RECOVERED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958709 GII DSH ART TRL 1-2 9MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 71430454 11GM00278 03596010481344

    Patients

    Seq Age Sex Outcome Treatment
    1