BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QC F

    MDR report key: 18912406 · Received March 15, 2024

    Report

    Report Number
    8030965-2024-03693
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 15, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819384736
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J EMPLOYEE. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF WITH A RFNA IMPLANT FOR DISTAL FEMORAL FRACTURE. 1 OF 2 HOLES AT THE PROXIMAL SIDE INTERFERED WITH A DRILL. A SCREW WAS INSERTED INTO THE HOLE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE DELAY OF 15 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QC F THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535267 DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QC F DRILL BIT HTW SYNTHES GMBH 07611819384736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK - NAILS: RFNA