BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUSPENSORY FIXATION DEV

    MDR report key: 11556365 · Received March 23, 2021

    Report

    Report Number
    1219602-2021-00604
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 28, 2021
    Report Date
    April 21, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    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. 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. 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

    (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 AN ENDOBUTTON. 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
    451378 UNKN SUSPENSORY FIXATION DEV FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R