BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø2 W/MARKING L110/85 2FLUTE

    MDR report key: 9884723 · Received March 26, 2020

    Report

    Report Number
    8030965-2020-02322
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 17, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GFG
    UDI-DI
    07611819158962
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H11: B1, B2, B5, H1: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF ANOTHER COMPLAINT (B)(4). ALL INFORMATION FOR THIS EVENT WILL BE CAPTURED ON MANUFACTURER REPORT NUMBER 8030965-2020-02663. 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 INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF ANOTHER COMPLAINT (B)(4). ALL INFORMATION FOR THIS EVENT WILL BE CAPTURED ON MANUFACTURER REPORT NUMBER 8030965-2020-02663.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS COMPANY REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WHILE DRILLING A SURGICAL PROCEDURE ON (B)(6) 2020, THE TIP OF THE DRILL BIT BROKE OFF. THE TIP COULD NOT BE REMOVED, THEREFORE, REMAINS INSITU. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348134 DRILL BIT Ø2 W/MARKING L110/85 2FLUTE BIT, MILLING STERILE AND NON GFG OBERDORF SYNTHES PRODUKTIONS GMBH 9524036 07611819158962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention