BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ABSORBABLE FAST-FIX DEV

    MDR report key: 11572237 · Received March 25, 2021

    Report

    Report Number
    1219602-2021-00684
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    February 28, 2021
    Report Date
    April 22, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. NO PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, INSTRUCTIONS FOR USE REVIEW, AND RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. ATTEMPTS TO OBTAIN MEDICAL DOCUMENTS WERE UNSUCCESSFUL AND THUS A THOROUGH MEDICAL INVESTIGATION WAS NOT PERFORMED. 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. 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 (B)(4). LITERATURE: THE CLINICAL RESEARCH OF THE ARTHROSCOPIC MINIMALLY INVASIVE SURGERY TREATMENT FOR DOUBLE-BUNDLE RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW, "THE CLINICAL RESEARCH OF THE ARTHROSCOPIC MINIMALLY INVASIVE SURGERY TREATMENT FOR DOUBLE-BUNDLE RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT", 2 PATIENTS DEVELOPED A JOINT INFECTION AFTER SURGERY WITH A FAST-FIX. THE COMPLICATIONS WERE TREATED WITH JOINT ASPIRATION AND JOINT DEBRIDEMENT. NECROTIC TISSUE WAS REMOVED USING A LARGE AMOUNT OF SODIUM CHLORIDE TO FLUSH OUT THE JOINT. A FLUSH TUBE WAS PLACED AND ANTIBIOTICS ADMINISTERED INTRAVENOUSLY. THE JOINT SPACE WAS CONTINUOUSLY FLUSHED WITH GENTAMICIN. THE OUTCOME FOR THE PATIENTS WAS GOOD. NO FURTHER INFORMATION IS AVAILABLE. 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
    468516 UNKN ABSORBABLE FAST-FIX DEV SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R