BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED EI

    MDR report key: 11112792 · Received January 4, 2021

    Report

    Report Number
    1219602-2021-00014
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 9, 2020
    Report Date
    March 31, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K072322
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5 AND PMA/510(K)NUMBER WERE UPDATED. H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE CONTACT WITH ANOTHER SOURCE OR STRESS ON THE NEEDLE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. A REVIEW OF THE COMPLAINT REVEALED THERE WERE NO PATIENT INJURIES REPORTED AND NO APPARENT PATIENT IMPACT BASED ON THE DETAILS PROVIDED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION. H1 WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A REVIEW OF THE INSTRUCTIONS FOR USE FOUND: ¿READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. DO NOT BEND DELIVERY NEEDLE. DELIVERY INSTRUMENTATION IS REQUIRED FOR PROPER PLACEMENT OF THE IMPLANTS FOR OPTIMAL SURGICAL RESULT. SLIDE THE GOLD TRIGGER FORWARD TO ADVANCE THE SECOND IMPLANT (T2) INTO THE READY POSITION.¿ A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A REVIEW OF THE COMPLAINT REVEALED THERE WERE NO PATIENT INJURIES REPORTED AND NO APPARENT PATIENT IMPACT BASED ON THE DETAILS PROVIDED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING THE ULTRA FAST-FIX ASSEMBLY - CURVED, T2 DID NOT TRIGGER. THE T1 IMPLANT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SOLVED WITH A NON-SIGNIFICANT SURGICAL DELAY WITH NO PATIENT HARM USING A BACK UP DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING THE ULTRA FAST-FIX ASSEMBLY - CURVED, T2 DID NOT TRIGGER. THE MALFUNCTION WAS SOLVED WITH A DELAY SHORTER THAN 30 MINUTES WITH NO PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5889 ULTRA FAST-FIX ASSEMBLY - CURVED EI SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2053347

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention