BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER

    MDR report key: 8910360 · Received August 20, 2019

    Report

    Report Number
    8030965-2019-67505
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Report Date
    July 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXZ
    UDI-DI
    07611819880313
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. PART: 03.607.513; LOT: 8853146; MANUFACTURING SITE: UMKIRCH B. FREIBURG; RELEASE TO WAREHOUSE DATE: MARCH 07, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CABLE CUTTER BROKE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705800 CABLE CUTTER CUTTER, WIRE HXZ OBERDORF SYNTHES PRODUKTIONS GMBH 8853146 07611819880313

    Patients

    Seq Age Sex Outcome Treatment
    1