BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED FOR 03.511.009

    MDR report key: 15895958 · Received December 1, 2022

    Report

    Report Number
    8030965-2022-10502
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    November 9, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HBE
    UDI-DI
    10887587014425
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL DEVICE PRODUCT CODES: ERL, DZI. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A J&J EMPLOYEE. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 DURING SURGERY, THE DRILL BIT GOT UNUSUALLY HOT AND BURNED THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER CHANGING THE DRILL BIT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED FOR 03.511.009. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663076 MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED FOR 03.511.009 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE SYNTHES GMBH 03.511.340 10887587014425

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Unknown Required Intervention