BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE

    MDR report key: 12546378 · Received September 29, 2021

    Report

    Report Number
    1020279-2021-07325
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 3, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NHT
    UDI-DI
    03596010199225
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES FOR THE LISTED DEVICE; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS 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. 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.

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER: CASE- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A THR SURGERY, THE HANDLE OF A T-HANDLE WAS NOTICED TO BE CRACKED DUE TO YEARS OR EXCESSIVE USAGE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446751 T-HANDLE ASSAY, NUCLEIC ACID AMPLIFICATION, BACILLUS ANTHRACIS NHT SMITH & NEPHEW, INC. 71364006 UNKNOWN 03596010199225

    Patients

    Seq Age Sex Outcome Treatment
    1