BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDOBUTTON DEVICE

    MDR report key: 12470964 · Received September 14, 2021

    Report

    Report Number
    1219602-2021-01991
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    March 27, 2002
    Report Date
    December 23, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE A FAILURE OF A CONCOMITANT DEVICE. NO CONCLUSIONS CAN BE MADE FROM THIS PUBLICATION AS ITS LIMITED TO THE INFORMATION PROVIDED AND FURTHER INVESTIGATION IS NOT POSSIBLE. IT WAS REPORTED THAT THE PATIENT WAS NO LONGER IN PAIN. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. 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 THERE WAS INSUFFICIENT INFORMATION TO TIE THE REPORTED COMPLAINT TO SPECIFIC LINE ITEMS WITHIN THE RISK FILE. 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). DOI: 10.1007/S00167-002-0287-X. KARAOGLU S, HALICI M, BAKTIR A. AN UNIDENTIFIED PITFALL OF ENDOBUTTON USE: CASE REPORT. KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2002 JUL;10(4):247-9. EPUB 2002 MAR 27. PMID: 12172720.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW "AN UNIDENTIFIED PITFALL OF ENDOBUTTON USE: CASE REPORT", 1 PATIENT EXPERIENCED PAIN AT THE DISTAL FIXATION SITE, REQUIRING A REVISION SURGERY. DURING THE SECOND-LOOK ARTHROSCOPY THE RECONSTRUCTED ACL LOOKED SECURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363674 UNKNOWN ENDOBUTTON DEVICE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention