BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL

    MDR report key: 4148730 · Received October 7, 2014

    Report

    Report Number
    2520274-2014-13958
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 11, 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 COMMON DEVICE NAME: DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: IT WAS REPORTED THE DRILL BIT WAS BROKEN DUE TO A CONTACT WITH SOMETHING UNKNOWN (MIGHT BE A RETRACTOR) WHEN THE SURGEON INSERTED IT IN THE ORAL CAVITY. THE INCIDENT DID NOT INTERRUPT THE OPERATION AS A SPARE DRILL BIT WAS USED. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629046 Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL DRILL, BONE, POWERED DZI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1