BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUTUREFIX ANCHOR

    MDR report key: 22701852 · Received August 4, 2025

    Report

    Report Number
    1219602-2025-01908
    Event Type
    Injury
    Date Received
    August 4, 2025
    Report Date
    August 4, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: DESCAMPS, J., GRECO, V., CHELLI, M., & BOILEAU, P. (2024). THE ARTHROSCOPICALLY GUIDED BRISTOW-LATARJET PROCEDURE WITH CORTICAL BUTTON FIXATION: A MINIMUM 10-YEAR FOLLOW-UP. THE AMERICAN JOURNAL OF SPORTS MEDICINE, 52(11), 2815-2825. H11 H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "THE ARTHROSCOPICALLY GUIDED BRISTOW-LATARJET PROCEDURE WITH CORTICAL BUTTON FIXATION", 1 PATIENT HAD RECURRENCE INSTABILITY WITH A TRUE SHOULDER DISLOCATION AFTER A BANKART REPAIR PROCEDURE USING A SUTURE BUTTON, SUTUREFIX ANCHOR AND LATARJET GUIDE. PATIENT UNDERWENT A LABRAL REPAIR WITH THE EDEN-HYBINETTE PROCEDURE USING AN ILIAC CREST BONE GRAFT. PATIENT WAS STABLE AFTER FOLLOW UP. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203138 UNKN SUTUREFIX ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| O UNKN JOINT REPAIR DEV.| UNKN MANUAL INSTR.