BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.0MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM

    MDR report key: 2023843 · Received March 14, 2011

    Report

    Report Number
    8030965-2011-00083
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LOT NUMBER REPORTED AS F-11417. MANUFACTURE SITE AND MANUFACTURE DATE HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DURING A PROCEDURE AT (B)(6), THE SURGEON WAS DRILLING IN THE MANDIBLE TO PLACE A SCREW AND THE DRILL BIT BROKE OFF IN THE BONE. THE TIP OF THE DRILL BIT REMAINS IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.0MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM 1.0MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5M HWE SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention