BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUSPENSORY FIXATION DEVICE

    MDR report key: 12471087 · Received September 14, 2021

    Report

    Report Number
    1219602-2021-01994
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    February 2, 2001
    Report Date
    October 26, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. 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 REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. IN THE STUDY, IT REPORTS THAT ONE PATIENT HAD AN EARLY COMPLICATION WITH DEEP INFECTION AND WAS SUCCESSFULLY RE-OPERATED ON WITH AN IPSILATERAL BPTB GRAFT 5 MONTHS AFTER THE INITIAL RECONSTRUCTION. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. 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 INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4). ERIKSSON K, HAMBERG P, JANSSON E, LARSSON H, SHALABI A, WREDMARK T. SEMITENDINOSUS MUSCLE IN ANTERIOR CRUCIATE LIGAMENT SURGERY: MORPHOLOGY AND FUNCTION. ARTHROSCOPY. 2001 OCT;17(8):808-17. DOI: 10.1016/S0749-8063(01)90003-9. PMID: 11600977.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW "SEMITENDINOSUS MUSCLE IN ANTERIOR CRUCIATE LIGAMENT SURGERY: MORPHOLOGY AND FUNCTION", ONE PATIENT HAD AN EARLY COMPLICATION WITH DEEP INFECTION AND WAS SUCCESSFULLY RE-OPERATED ON WITH AN IPSILATERAL BPTB GRAFT 5 MONTHS AFTER THE INITIAL RECONSTRUCTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364763 UNKNOWN SUSPENSORY FIXATION DEVICE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention