BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON BLK COATED 130 UP 180X1MM THIN

    MDR report key: 5391446 · Received January 26, 2016

    Report

    Report Number
    2916714-2016-00048
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Report Date
    May 23, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    LRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: ON-GOING

    Additional Manufacturer Narrative · 0

    CORRECTION: SEE SECTION B5 FOR RELATED MED WATCH REPORTS CORRECTION: AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: PORTUGAL. BROKEN FOOT PLATE. (B)(4).

    Description of Event or Problem · 0

    MULTIPLE MEDWATCH REPORTS BEING FILED THAT ARE RELATED/SIMILAR TO THIS EVENT, PLEASE SEE: 2916714-2016-00043, 2916714-2016-00044, 2916714-2016-00045, 2916714-2016-00046, 2916714-2016-00047, 2916714-2016-00048.

    Additional Manufacturer Narrative · 1

    THE FOOTPLATE OF THE PUNCH IS BENT DOWNWARD. BOTH CUTTING EDGES (THE PUSHER AND THE MAIN PART) ARE SEVERLY DEFORMED. IN ADDITION, THE MOUTH OF THE PUSHER HAS ORGANIC RESIDUES WHICH IS A RESULT OF IMPROPER CLEANING. THE DEFORMATIONS WERE ACCRUED BY OVERSTRAINING AND EXCESSIVE FORCE. CORRECTIVE/PREVENTIVE ACTION IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49065 KERRISON BLK COATED 130 UP 180X1MM THIN BONE PUNCHES LRY AESCULAP AG FK906B 52154980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other