BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUTUREFIX ANCHOR

    MDR report key: 20660322 · Received November 11, 2024

    Report

    Report Number
    1219602-2024-02404
    Event Type
    Injury
    Date Received
    November 11, 2024
    Report Date
    November 11, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE (B)(4). ARTICLE: IBÁN, M. A. R., DÍAZ, R. R., DE RUS AZNAR, I., COMINO, C. V., & HEREDIA, J. D. (2023). ANATOMIC ACROMIOCLAVICULAR AND CORACOCLAVICULAR LIGAMENT RECONSTRUCTION WITH ALLOGRAFT IS EFFECTIVE FOR THE MANAGEMENT OF NON-ACUTE ACROMIOCLAVICULAR DISLOCATIONS. INJURY, 54, 111047. H10 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 ANATOMIC ACROMIOCLAVICULAR AND CORACOCLAVICULAR LIGAMENT RECONSTRUCTION WITH ALLOGRAFT IS EFFECTIVE FOR THE MANAGEMENT OF NON-ACUTE ACROMIOCLAVICULAR DISLOCATIONS" BETWEEN JANUARY 2015 TO JANUARY 2020, 1 PATIENT HAD INSUFFICIENT INITIAL REDUCTION (54% DISPLACEMENT), PROGRESSIVE LOSS OF REDUCTION (FINALLY 152%) AND A POOR FUNCTIONAL OUTCOME 28 MONTHS AFTER PROCEDURE WITH EVIDENT DYSKINESIA AND CLEAR ANTEROPOSTERIOR AND CRANIOCAUDAL INSTABILITY OF THE DISTAL CLAVILE AFTER AN ANATOMIC ACROMIOCLAVICULAR AND CORACOCLAVICULAR LIGAMENT RECONSTRUCTION PROCEDURE USING TWO(2) SUTUREFIX 1.7MM DEVICES. PATIENT DECLINED ANY OTHER ADDITIONAL PROCEDURES. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975387 UNKN SUTUREFIX ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other