BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047

    MDR report key: 11916089 · Received June 1, 2021

    Report

    Report Number
    2939274-2021-02706
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    10887587012971
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: DZI, ERL, HBE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) BILATERAL MANDIBLE FRACTURE ON (B)(6) 2021, THE DRILL BIT BROKE WHILE DRILLING TO PLACE A SCREW. INTRAORAL INCISION WAS EXTENDED TO RETRIEVE THE BROKEN TIP OF THE BRILL BIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN (15) MINUTE DELAY. THERE WERE NO OTHER PATIENT CONSEQUENCES. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813369 MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047 INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.503.476 10887587012971

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention