BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII DSH ART TRL 1-2 9MM

    MDR report key: 10004780 · Received April 28, 2020

    Report

    Report Number
    1020279-2020-01397
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    April 3, 2020
    Report Date
    May 18, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    UDI-DI
    03596010481344
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE FRACTURED IN HALF AND BOTH PIECES WERE RETURNED. THE DEVICE WAS MANUFACTURED IN 2004 AND SHOWS SIGNS OF EXTENSIVE WEAR/USAGE. THE MEDICAL INVESTIGATION CONCLUDED THAT NO RELEVANT CLINICAL INFORMATION HAS BEEN PROVIDED. WITHOUT THE REQUESTED CLINICAL INFORMATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE RENDERED. HOWEVER, PER COMMUNICATIONS, THE DEVICE PIECES DID NOT FALL IN THE PATIENTS¿ WOUND, THERE WAS NO DELAY AND A BACKUP WAS USED. IN ADDITION, THERE WAS NO REPORT OF INJURY TO THE PATIENT. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-ASSESSED. 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. AT THIS TIME, WE DO NOT HAVE 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. SHOULD 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 THE INSERT TRIAL WAS BROKEN DURING A CASE. THE DEVICE DID NOT BREAK INSIDE THE PATIENT'S WOUND. ADDITIONALLY, NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING AN S&N BACKUP DEVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469098 GII DSH ART TRL 1-2 9MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM SMITH & NEPHEW, INC. 71430454 14AB00119 03596010481344

    Patients

    Seq Age Sex Outcome Treatment
    1