BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE

    MDR report key: 14747733 · Received June 20, 2022

    Report

    Report Number
    9612488-2022-00019
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 23, 2022
    Manufacturer
    SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    10886982297808
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    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 NARRATIVE: ADDITIONAL PROCODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    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: H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 04.043.245S. LOT # 679P812. MANUFACTURING SITE: JABIL BETTLACH. RELEASE TO WAREHOUSE DATE: 22.MARCH.2022. EXPIRY DATE: 29.FEBRUARY.2032. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. 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 DURING A PROCEDURE ON (B)(6) 2022, WHILE IMPLANTING A 10X375 SYNTHES TIBIAL ADVANCE NAIL, THE PIN THAT HELD THE SPRING IN PLACE ON THE IMPACTOR HANDLE HAD BROKEN. THIS ALLOWED FOR THE RELEASE MECHANISM TO MOVE FREELY ON THE IMPACTOR. THE SURGEON NOTED THAT THE AIMING ARM WAS MOVING INDEPENDENTLY OF THE NAIL, AND THEY ATTEMPTED TO RE-TIGHTEN THE CONNECTING SCREW, BUT IT WAS NOT LOOSE. UPON FURTHER INSPECTION OF THE NAIL/AIMING ARM ATTACHMENT POINT, IT LOOKED LIKE THE NAIL WAS BEGINNING TO SPLAY AT ITS PROXIMAL END. THE SURGEON WAS ABLE TO IMPACT THE REST OF THE NAIL UNTIL IT WAS FULLY INSERTED INTO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY OTHER COMPLICATIONS. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252938 TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE NAIL, FIXATION, BONE JDS SYNTHES PRODUKTIONS GMBH 04.043.245S 679P812 10886982297808

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DRIVING CAP| UNK - BIOMATERIAL - CEMENT: TRAUMACEM| UNK - INSERTION INSTRUMENTS: CONNECTING: TRAUMA| UNK - NAIL INSERTION HANDLES