BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS INSTRUMENT PROJECT (LEGION)

    MDR report key: 10971857 · Received December 8, 2020

    Report

    Report Number
    1020279-2020-07232
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 10, 2020
    Report Date
    February 5, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KIL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEPTH OF THE RESECTION WAS FOUND TO BE FADED, RENDERING THE DEVICE INOPERABLE. THE DEVICE SHOWS SIGNS OF EXTENSIVE USE. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINT 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. AT THIS TIME, WE DO NOT HAVE 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 REPEATED USE CAN OCCUR. 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. SHOULD 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.

    Additional Manufacturer Narrative · 1

    CASE- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON NOTED THAT THE INDICATE DEPTH OF THE RESECTION WAS FADED AND UNABLE TO BE READ. PROCEDURE FINISHED WITH THE SAME DEVICE. NO HARM OR INJURY REPORTED ON PATIENT. THIS OCCURRED DURING A TKA PROCEDURE, WHILE THE DEVICE WAS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428882 EXPRESS INSTRUMENT PROJECT (LEGION) POSITIONER, SOCKET KIL SMITH & NEPHEW, INC. 080414

    Patients

    Seq Age Sex Outcome Treatment
    1