BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 12751031 · Received November 4, 2021

    Report

    Report Number
    1020279-2021-07830
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 9, 2021
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS THE TIP OF THE REF BALL JNT SCREWDRIVER SHAFT BROKE OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE DEVICE. THIS INSTRUMENT EXHIBITS SIGNS OF SIGNIFICANT USE AND WEAR. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE, INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS THE TIP OF THE REF BALL JNT SCREWDRIVER SHAFT BROKE OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE DEVICE. THIS INSTRUMENT EXHIBITS SIGNS OF SIGNIFICANT USE AND WEAR. THE CURRENT INVESTIGATION IS STILL ON GOING. A SUPPLEMENTAL MDR WILL BE SENT WITH THE RESULTS OF INVESTIGATION THAT ARE STILL PENDING. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REF BALL JNT SCREWDRIVER SHAFT HAS AN UNKNOWN FAILURE. NO PATIENT INVOLVED. THE INVESTIGATION FOUND THAT THE TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652963 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 01KM00090 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown