BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 9853610 · Received March 19, 2020

    Report

    Report Number
    1020279-2020-00919
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    March 18, 2020
    Report Date
    May 12, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 HEX TIP FRACTURED OFF THE DEVICE AND WAS RETURNED. THE DEVICE WAS MANUFACTURED IN 2010 AND SHOWS 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 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE END OF THE REFLECTION BALL JNT SCREWDRIVER SHAFT DRIVER BROKE OFF WHEN INSERTING THE ACETABULUM SCREW. ALL THE PIECES WERE RECOVERED FROM THE PATIENT. THERE WAS NO SUBSTANTIAL PROCEDURAL DELAY BECAUSE AN S&N BACKUP REFLECTION BALL JNT SCREWDRIVER SHAFT WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT OR THE STAFF. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315832 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 10AM14259 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1