BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE

    MDR report key: 3973483 · Received August 1, 2014

    Report

    Report Number
    2520274-2014-12941
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN K-WIRE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT WAS USED FOR THE RADIAL HEAD FRACTURE CASE. DURING THE OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE, THE SURGEON INSERTED THE 1.1 MM GUIDE WIRE THROUGH THE SLEEVE AND MEASURED THE LENGTH FOR SCREW INSERTION. WHEN DRILLING THROUGH THE SLEEVE, THE BLADE OF THE DRILL BIT BROKE. IT WAS FOUND THAT THREE BROKEN PIECES WERE LEFT IN THE PATIENTS BODY. BROKEN PIECES WERE ALL REMOVED FROM THE PATIENT. AFTER THAT, BONE REDUCTION WAS DONE AGAIN WITH TWO K-WIRES, TWO HEADLESS COMPRESSION SCREWS (HCS), AND ARTIFICIAL BONE (GRANULE TYPE). THE K-WIRE WAS LEFT IN THE PATIENT¿S BODY AND THE OPERATION WAS COMPLETED. IT WAS NOTED THAT THE PATIENT BONE QUALITY WAS GOOD. EXTRA BONE CUTTING WAS DONE WHICH RESULTED IN A THIRTY MINUTE SURGICAL DELAY. THIS REPORT IS FOR AN UNKNOWN K-WIRE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450641 GUIDE FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR