BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBTROC LAG SCREW DRIVER

    MDR report key: 8921830 · Received August 22, 2019

    Report

    Report Number
    1020279-2019-03132
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 24, 2019
    Report Date
    October 20, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSB
    UDI-DI
    03596010560612
    PMA / PMN Number
    K122170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE TIP OF THE THREADS ON THE RETAINING ROD FRACTURED OFF, RENDERING THE DEVICE INOPERABLE. THE FRACTURED THREADS WERE NOT RETURNED. ONLY ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS MANUFACTURED IN 2017 AND EXHIBITS SIGNS OF SIGNIFICANT 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 COMPLAINTS WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THESE COMPLAINTS; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREADS ON DRIVERS SHEARED WHEN INSERTING. BACKUP WAS AVAILABLE AND NO DELAY WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714866 SUBTROC LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SMITH & NEPHEW, INC. 17ESP0013 03596010560612

    Patients

    Seq Age Sex Outcome Treatment
    1