BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 12329268 · Received August 16, 2021

    Report

    Report Number
    1020279-2021-06391
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    August 2, 2021
    Report Date
    October 9, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE HEAD OF A REF BALL JNT SCREWDRIVER SHAFT BROKE DURING SCREW INSERTION. NO CLINICALLY RELEVANT SUPPORTING DOCUMENTATION WAS PROVIDED FOR INCLUSION IN THIS MEDICAL INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED BREAKAGE OF THE HEAD OF THE SCREWDRIVER SHAFT COULD NOT BE DETERMINED. THE BROKEN HEAD OF THE REF BALL JNT SCREWDRIVER SHAFT IS NON-IMPLANTABLE COMPROMISED OF 17.4SS MATERIAL COMMONLY USED IN SURGICAL DEVICE. THE REF BALL JNT SCREWDRIVER WAS MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR LONG-TERM INTERNAL TISSUE EXPOSURE AND LONG-TERM IMPLANTATION DATA IS NOT AVAILABLE. IF THE BROKEN HEAD WAS RETAINED INSIDE OF THE PATIENT, WE CANNOT RULE OUT THE POSSIBILITY OF LOCAL SKIN IRRITATION, MICRO-MOTION AND OR MIGRATION OF THE RETAINED PIECE. BASED ON THE INFORMATION PROVIDED, SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. SINCE THERE WERE NO PATIENT INJURY AS CONSEQUENCE OF THIS PROBLEM; NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT PATIENT INFORMATION BE PROVIDED, THIS COMPLAINT WOULD BE RE-ASSESSED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES FOR THE LISTED BATCH; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. AT THIS TIME, WE HAVE NO 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. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THR SURGERY, THE HEAD OF A REF BALL JNT SCREWDRIVER SHAFT BROKE OFF DURING SCREW INSERTION. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220051 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 15KSY0034 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention