BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 10405181 · Received August 13, 2020

    Report

    Report Number
    1020279-2020-03913
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 19, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE DEVICE, INTENDED USE IN TREATMENT, WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS THE SCREWDRIVER PART OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE DEVICE. ALSO THE DEVICE IS ROUNDED OFF ON ONE END AND THERE ARE SEVERAL NICKS ON THE METAL OF THE DEVICE. THIS INSTRUMENT EXHIBITS SIGNS OF SIGNIFICANT USE AND WEAR. THE DEVICE MANUFACTURED IN 2013. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH WITH THE SAME FAILURE MODE. 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 INSTRUMENTS THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. EXPECTED WEAR/TEAR IS LIKELY THE PROBABLE CAUSE 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. 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 · 0

    IT WAS REPORTED THAT DURING AN OFFICE INSPECTION THE REF BALL JNT SCREWDRIVER SHAFT WAS FOUND TO BE BROKEN. NO CASE RELATED THEREFORE NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OFFICE INSPECTION THE REF BALL JNT SCREWDRIVER SHAFT WAS FOUND TO BE BROKEN. NO CASE RELATED THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867850 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 13DSY0002 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1