BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAP SPACER

    MDR report key: 14051043 · Received April 8, 2022

    Report

    Report Number
    1020279-2022-01655
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 16, 2022
    Report Date
    August 25, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWT
    UDI-DI
    00885556578445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, 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. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. 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. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. 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 · 0

    INTERNAL COMPLAINT REFERENCE CASE- (B)(4).

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS THE DEVICE FRACTURED INTO TWO PIECES. BOTH PIECES OF THE DEVICE WAS RETURNED FOR EVALUATION. THIS DEVICE SHOWS SIGNIFICANT SIGNS OF WEAR AND USE. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, 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. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. AS THE DEVICE BROKE AND IT CANNOT LONGER FIT ITS PURPOSE, THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD BE CORROBORATED. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE 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 FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SURGERY, THE GAP SPACER BROKEN WHILE IN USE INSIDE THE PATIENT. NO PIECE FELL INTO THE PATIENT INCISION. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160388 GAP SPACER TEMPLATE HWT SMITH & NEPHEW, INC. 71935180 19LDN7779 00885556578445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown