BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR

    MDR report key: 686 · Received June 9, 1992

    Report

    Report Number
    686
    Event Type
    Malfunction
    Date Received
    June 9, 1992
    Date of Event
    May 14, 1992
    Report Date
    May 21, 1992
    Manufacturer
    BAXTER SURGICAL
    Product Code
    EJX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    VERY SMALL PIECE, 1MM, TIP OF NEEDLE BROKEN OFF, ROTATOR CUFF REPAIR, NOT FOUND. PHYSICIAN TO TAKE X-RAYS IN OFFICE 5/20/92. IN AREA THAT WILL NOT CAUSE PROBLEM NOR MIGRATE. MANUFACTURE REPRESENTATIVE NOTIFIED, RUSS BROWNDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR REGULAR SURGEONS 1/2 CIRCLE CUTTING EDGE EJX BAXTER SURGICAL NONE C53AN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other