BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6711772 · Received July 13, 2017

    Report

    Report Number
    3000270450-2017-10238
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    July 5, 2017
    Report Date
    July 6, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZI
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: DZJ (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED.COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MFR. REVIEW/INVESTIGATION. 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. 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 SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE 1.5MM DRILL BIT BROKE DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT WITH 8MM STOP THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492051 Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL DRILL, BONE, POWERED DZI SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1