BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE/ROD CUTTER

    MDR report key: 3771158 · Received April 24, 2014

    Report

    Report Number
    2520274-2014-11041
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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

    IT WAS REPORTED THAT THE SURGEON WAS BENDING THE TRIAL ROD TO FIT THE PATIENT¿S ANATOMY AND IT SNAPPED. THEN, WHEN HE WENT TO CUT THE EXCESS ROD THE CUTTING SURFACE OF THE PLIERS, IT CHIPPED OFF. THE CASE WAS NOT PROLONGED AS ANOTHER ROD CUTTER WAS USED. THERE WAS NO HARM TO THE PATIENT NOTED. NO FRAGMENTS WENT NEAR THE PATIENT AS THE ROD CUTTING TAKES PLACE AWAY FROM THE PATIENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250165 PLATE/ROD CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1