BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM ROC FASTENER

    MDR report key: 83166 · Received April 4, 1997

    Report

    Report Number
    1222933-1997-00002
    Event Type
    Malfunction
    Date Received
    April 4, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 31, 1997
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC BANKART REPAIR. AFTER DEPLOYMENT OF THE ANCHOR, THE DR PULLED ON THE SUTURE AND THE ANCHOR BROKE. THE DR DECIDED TO PERFORM TRANSGLENOID SUTURING TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.8MM ROC FASTENER Implant BONE ANCHOR KGS INNOVASIVE DEVICES, INC. NA 10547

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other