BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Ø2.4MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMANDBL

    MDR report key: 5100327 · Received September 24, 2015

    Report

    Report Number
    2520274-2015-16114
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    DZI
    PMA / PMN Number
    PK082649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: 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. 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

    IT WAS REPORTED THAT A PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT THAT REQUIRED AN OPEN REDUCTION INTERNAL FIXATION. DURING THE SURGERY A DRILL BIT FROM A 90 DEGREE SCREWDRIVER BROKE. THE TIP BROKE OFF IN THE BONE. THE SURGEON OPTED TO LEAVE THE DRILL BIT IN THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION REQUIRED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630881 Ø2.4MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMANDBL DRILL, BONE, POWERED DZI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention