BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BONE ANCHOR

    MDR report key: 6443686 · Received March 29, 2017

    Report

    Report Number
    1221934-2017-10125
    Event Type
    Injury
    Date Received
    March 29, 2017
    Report Date
    March 6, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. THREE PATIENTS SUFFERED RERUPTURES POST PROCEDURE. THE AUTHOR WAS CONTACTED FOR FURTHER INFORMATION REGARDING EACH CASE BUT NONE WAS RETRIEVED. IT CANNOT BE CONFIRMED THAT THESE ISSUES HAVE BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAINS RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI - UNAVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: SURGICAL REPAIR OF THE DISTAL BICEPS BRACHII TENDON: A COMPARATIVE STUDY OF THREE SURGICAL FIXATION TECHNIQUES. AUTHORS: CITAK, MUSTAFA AND "ET AL" KNEE SURG SPORTS TRAUMATOL ARTHROSC (2011) 19:1936-1941. (B)(4). THREE PATIENTS EXPERIENCED RERUPTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227074 UNK BONE ANCHOR MITEK IMPLANTS HWC DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other