BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

    MDR report key: 4012392 · Received August 15, 2014

    Report

    Report Number
    2520274-2014-13166
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    DZI
    PMA / PMN Number
    PK082649
    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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; DZJ. 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 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DRILL BIT WAS BROKEN DURING PROCEDURE. THE BROKEN PIECE REMAINED IN THE PATIENTS BODY. THERE IS NO ADVERSE CONSEQUENCE TO THE PATIENT. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS 1 OF 1 OR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489705 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1