BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP SPACER

    MDR report key: 12076229 · Received June 28, 2021

    Report

    Report Number
    1020279-2021-05462
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    June 4, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWT
    UDI-DI
    00885556578445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. 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. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED OR PRODUCT INFORMATION, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS 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 A TKA, THE STICK OF A GAP SPACER SNAPPED WHEN USED TO ASSESS GAPS INSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973574 GAP SPACER TEMPLATE HWT SMITH & NEPHEW, INC. 71935180 UNK 00885556578445

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R