BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PEEK SUTURE ANCHOR

    MDR report key: 18882088 · Received March 11, 2024

    Report

    Report Number
    1219602-2024-00456
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    September 5, 2023
    Report Date
    March 11, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K152566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). KIM, Y. J., JI, J. H., PARK, S. E., PARIKH, D., & LEE, W. J. (2024). COMPARISON BETWEEN ARTHROSCOPIC SUTURE ANCHOR FIXATION AND OPEN PLATE FIXATION IN THE GREATER TUBEROSITY FRACTURE OF THE PROXIMAL HUMERUS. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, 34(1), 621-631. HTTPS://DOI.ORG/10.1007/S00590-023-03684-X 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 "COMPARISON BETWEEN ARTHROSCOPIC SUTURE ANCHOR FIXATION AND OPEN PLATE FIXATION IN THE GREATER TUBEROSITY FRACTURE OF THE PROXIMAL HUMERUS", 1 PATIENT SUFFERED FROM GT FRACTURE-DISLOCATION COMBINED WITH BRACHIAL PLEXUS INJURY AFTER AN ARTHROSCOPIC SUTURE ANCHOR FIXATION PROCEDURE USING A FOOTPRINT ANCHOR. EMG CONFIRMED BRACHIAL PLEXUS INJURY AND THE SYMPTOMS IMPROVED COMPLETELY AFTER 6 OR 9 MONTHS LATER BY CONSERVATIVE TREATMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456827 UNKNOWN PEEK SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| O