BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN NONABSORBABLE FAST-FIX DEV

    MDR report key: 11909334 · Received May 31, 2021

    Report

    Report Number
    1219602-2021-01253
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 11, 2021
    Report Date
    January 4, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT REVIEW, AND AN INSTRUCTIONS FOR USE/DEVICE LABELING REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A CLINICAL REVIEW STATES THAT WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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 INVESTIGATION WILL BE REOPENED FOR EVALUATION. H11: CORRECTED DATA G4, PMA/510(K)NUMBER ADDED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE: (B)(4). LITERATURE: ARTHROSCOPIC MENISCAL REPAIR WITH FAST-FIX SUTURE DEVICE: A FIVE-YEAR FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW "ARTHROSCOPIC MENISCAL REPAIR WITH FAST-FIX SUTURE DEVICE: A FIVE-YEAR FOLLOW-UP REPORT", AT AN AVERAGE OF 3.5 YEARS AFTER SURGERY WITH A FAST-FIX, 5 PATIENTS HAD AN UNHEALED MENISCUS WITH TENDERNESS/SWELLING/JOINT LOCKING, AND A POSITIVE MCMURRAY TEST. PATIENTS WERE RE-HOSPITALIZED AND HAD REVISION SURGERY, PATIENTS HAD TEARS IN THE RED & WHITE ZONE. RECURRENT MENISCAL INJURIES WERE FOUND AT THE LATERAL ANTERIOR HORN. THE COMPLICATIONS WERE TREATED WITH PARTIAL MENISCECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804291 UNKN NONABSORBABLE FAST-FIX DEV SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O