BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAILS: TIBIAL

    MDR report key: 20952138 · Received December 17, 2024

    Report

    Report Number
    8030965-2024-15120
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 2, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE PREVIOUSLY REPORTED EVENT UNDER MRN 8030965-2024-15120 AND 8030965-2024-15119 ARE NO LONGER CONSIDERED REPORTABLE AT THIS TIME AS THE DEVICES WERE REPORTED ON ANOTHER COMPLAINT. NO FURTHER FOLLOW-UPS WILL BE SENT UNDER MRN 8030965-2024-15120 AND 8030965-2024-15119.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 THE SURGEON NOTICED THAT THE ADVANCED TIBIAL NAIL AIMING DRILL SLEEVE WAS NOT ALIGNED TO THE PROXIMAL LOCKING HOLE OF THE ADVANCED TIBIAL NAIL. THE NEW WIRE THAT WAS PASSED THROUGH THE DRILL SLEEVE WAS HITTING THE NAIL POSTERIORLY. THE SURGEON WENT AHEAD AND IMPLANTED THE NAIL, BUT AS EXPECTED THE PROXIMAL LOCKING HOLES WEREN¿T LINING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487241 UNK - NAILS: TIBIAL NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown