BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/12MM STOP/50MM

    MDR report key: 11748265 · Received April 29, 2021

    Report

    Report Number
    8030965-2021-03436
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    UDI-DI
    07611819381117
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    THE PATIENT RETURNED FOR A MANDIBLE RECONSTRUCTION SURGERY BECAUSE THE BONE FAILED TO HEAL FULLY DUE TO AN INFECTION. THERE WERE NO SYMPTOMS IN RELATION TO THE BROKEN TIP. DURING THE SURGERY THE DRILL TIP WAS RETRIEVED. ALL PLATES AND SCREWS FROM THE INITIAL SURGERY WERE REMOVED. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN# QUANTITY: UNKNOWN).

    Additional Manufacturer Narrative · 1

    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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING A PLATING A MANDIBLE FRACTURE, THE TIP OF THE DRILL BIT SNAPPED OFF WHEN HE WAS 'ON THE WAY OUT' WITH THE DRILL. SEVERAL HOLES HAD ALREADY BEEN SUCCESSFULLY DRILLED AND SCREWS WERE PLACED, WHILE THE SURGEON WAS NOT USING THE DRILL GUIDE AT THAT TIME. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BROKEN TIP OF THE DRILL BIT WAS UNABLE TO BE RETRIEVED AND APPROXIMATELY 6MM FRAGMENTS WERE REMAINED INSIDE THE PATIENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/12MM STOP/50MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644283 MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/12MM STOP/50MM DRILL, BONE, POWERED DZI SYNTHES GMBH 07611819381117

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR UNK - SCREWS: TRAUMA.