BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP SPACER

    MDR report key: 13089720 · Received December 27, 2021

    Report

    Report Number
    1020279-2021-08861
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    December 7, 2021
    Report Date
    January 31, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWT
    UDI-DI
    00885556578445
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE WAS NOT RETURNED FOR EVALUATION BUT THE IMAGES PROVIDED WERE REVIEWED AND THE FRACTURE WAS CONFIRMED. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE, BUT NO SIMILAR EVENTS FOR THE BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. AN HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD BE CORROBORATED AS THE INSTRUMENT FRACTURED AND CAUSED A NON-SIGNIFICANT DELAY. 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, 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 · 0

    IT WAS REPORTED THAT, DURING TKA SURGERY, A GAP SPACER BROKE INSIDE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987672 GAP SPACER TEMPLATE HWT SMITH & NEPHEW, INC. 71935180 19GDN3321 00885556578445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other