BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 11382488 · Received February 25, 2021

    Report

    Report Number
    1020279-2021-01597
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    February 1, 2021
    Report Date
    July 19, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL INVESTIGATION CONCLUDED THAT PER COMPLAINT DETAILS, THE TIP OF A REFLECTION BALL JNT SCREWDRIVER SHAFT BROKE OFF INSIDE THE PATIENT DURING A THR; HOWEVER, ALL PIECES WERE RECOVERED WITH TWEEZERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. IT WAS COMMUNICATED THAT REQUESTED MEDICAL DOCUMENTATION WAS NOT AVAILABLE FOR REVIEW. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE EVENT COULD NOT BE FULLY ASSESSED. SINCE NO PATIENT INJURY/HARM, SURGICAL DELAY OR OTHER COMPLICATIONS WERE ALLEGED, FURTHER PATIENT IMPACT WOULD NOT BE ANTICIPATED AND NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. 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 HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. 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. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED OR PRODUCT INFORMATION, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE TIP OF A REFLECTION BALL JNT SCREWDRIVER SHAFT BROKE OFF. INCIDENT OCCURRED DURING A THR WITH INSTRUMENTS INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278625 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention