BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL ADVANCED Ø10 L315

    MDR report key: 16704253 · Received April 7, 2023

    Report

    Report Number
    8030965-2023-04344
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 20, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    07612334171504
    PMA / PMN Number
    K201336
    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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. PRODUCT CODE: 04.043.225S; LOT NO: 375P762; MANUFACTURING SITE: JABIL BETTLACH; RELEASE TO WAREHOUSE DATE: 07/10/2021; EXPIRY DATE: 01/09/2031. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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. ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HWC: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER'S OCCUPATION: REPORTER IS A J&J EMPLOYEE. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF SURGERY FOR TIBIAL SHAFT FRACTURE AND DISTAL FIBULA FRACTURE WITH THE NAIL IN QUESTION FOR TIBIAL SHAFT. IN THE SURGERY, A SUPRA PATERA APPROACH WAS ATTEMPTED, BUT THE PRESSURE ON THE PF JOINT WAS SO STRONG THAT THE SURGEON'S INDEX FINGER COULD NOT ENTER THE ENTRY POINT. EVEN WHEN PROTECTION SLEEVE LONG 8-13MM (STERILIZED) WAS USED, NAIL COULD NOT BE INSERTED, EVEN WITH OUTER SLEEVE 14.5 SUPRA PATERA FOR ETN. ALTHOUGH THE CUTANEOUS INCISION RANGE WAS EXTENDED AND THE PARA PATELLA APPROACH WAS SELECTED, THE ENTRY POINT WAS NOT CREATED WELL, AND THE INSERTION WAS DIRECTED POSTERIORLY INSTEAD OF ALONG THE EXTENSION LINE OF THE MEDULLARY CANAL. THE SURGEON SPECULATED THAT THE DRILL FOR THE PROXIMAL LOCKING SCREW HAD INTERFERED WITH THE NAIL BECAUSE THE NAILS WERE BENT. THE PROBLEM WAS SOLVED WITH A RADIO LUCENT DRILL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL ADVANCED Ø10 L315 THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441472 TIBIAL NAIL ADVANCED Ø10 L315 NAIL, FIXATION, BONE JDS SYNTHES GMBH 375P762 07612334171504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OUT PROTECT SL 14.5 F/ETN F/SUPRAPAT APP.| PROTECTION SLEEVE F/NAILS Ø8-13 FLEX LON.