BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 12545158 · Received September 29, 2021

    Report

    Report Number
    1020279-2021-07301
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 24, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE DEVICE, INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE REFLECTION BALL JNT SCREWDRIVER SHAFT HANDLE IS BROKEN RENDERING THE DEVICE INOPERATIVE. 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. 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. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, A REFLECTION BALL JNT SCREWDRIVER SHAFT HANDLE WAS BROKEN. AS THIS PROBLEM WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THR SURGERY, A REFLECTION BALL JNT SCREWDRIVER SHAFT HANDLE WAS BROKEN. IT REMAINS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SURGICAL DELAY. NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444994 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 01KM00090 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1