BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII DSH ART TRL 1-2 11MM

    MDR report key: 8604305 · Received May 13, 2019

    Report

    Report Number
    1020279-2019-01894
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 20, 2019
    Report Date
    August 6, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010512628
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICES CONFIRMED THE STATED FAILURE MODE. SMALL SECTIONS OF BOTH DEVICES FRACTURED OFF AND WERE RETURNED. THE DEVICES HAD SOME NICKS AND GOUGES IN SURFACE, PARTICULARLY AROUND THE FRACTURE SITES. THE DEVICES WERE MANUFACTURED IN 2010 AND 2011 AND EXHIBIT SIGNS OF EXTENSIVE WEAR/USAGE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCHES. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINTS WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THESE COMPLAINTS; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TKA THE DEVICE BROKE. ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397320 GII DSH ART TRL 1-2 11MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 10KM18574 03596010512628

    Patients

    Seq Age Sex Outcome Treatment
    1