BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXMEDF 1.25 DB J-LATCH/12 STOP/44.5

    MDR report key: 16584415 · Received March 21, 2023

    Report

    Report Number
    8030965-2023-03464
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 21, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    UDI-DI
    10887587012056
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER OCCUPATION: REPORTER IS A J&J SALES REPRESENTATIVE. 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 ON (B)(6) 2023, THAT DURING SURGERY THE DRILL BIT BROKE INTO THE PATIENT¿S TIBIA AND IT WAS LEFT THERE. THE ZIP SNAPPED OFF AND WAS LEFT INTO THE PATIENT¿S CONSTRUCTION BONE OF THE CONSTRUCTION. THERE WAS PATIENT INVOLVEMENT. BROKEN DRILL BIT WAS NOT RECOVERED THIS REPORT IS FOR ONE (1) MATRIXMEDF 1.25 DB J-LATCH/12 STOP/44.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11673 MATRIXMEDF 1.25 DB J-LATCH/12 STOP/44.5 DRILL, BONE, POWERED DZI SYNTHES GMBH 03.503.112 10887587012056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention