BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QFX SCREW 18MM

    MDR report key: 11816838 · Received May 13, 2021

    Report

    Report Number
    1020279-2021-04142
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 22, 2021
    Report Date
    August 4, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010623430
    PMA / PMN Number
    K090675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE HAS A SLIGHT BEND IN IT RENDERING THE DEVICE INOPERATIVE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. DAMAGE FROM MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. IF ANY ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING INSPECTION WAS FOUND A 2.0 MM QFX SCREW 18 MM BENT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718671 2.0MM QFX SCREW 18MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 71102285S UNK 03596010623430

    Patients

    Seq Age Sex Outcome Treatment
    1