BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOURNEY FEM IMPACT BUMPER RT

    MDR report key: 8681405 · Received June 9, 2019

    Report

    Report Number
    1020279-2019-02237
    Event Type
    Malfunction
    Date Received
    June 9, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 3, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010556455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. ONE OF THE ATTACHMENT POSTS FRACTURED OFF THE DEVICE AND WAS RETURNED. THE DEVICE WAS MANUFACTURED IN 2013 AND EXHIBITS SIGNS OF EXTENSIVE WEAR/USAGE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. 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 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 · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. ONE OF THE ATTACHMENT POSTS FRACTURED OFF THE DEVICE AND WAS RETURNED. THE DEVICE WAS MANUFACTURED IN 2013 AND EXHIBITS SIGNS OF EXTENSIVE WEAR/USAGE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. 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 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 THE PEG OF THE BUMPER BROKE OFF DURING IMPACTION. A DELAY OF 0 TO 30 MINUTES WAS REPORTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474841 JOURNEY FEM IMPACT BUMPER RT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 16AM20198 03596010556455

    Patients

    Seq Age Sex Outcome Treatment
    1 71642680 / 15LT61395| 71649632 / 17ET86910