BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFNA END CAP EXTENS. 0 TAN

    MDR report key: 18046982 · Received November 1, 2023

    Report

    Report Number
    8030965-2023-13644
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 12, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819648708
    PMA / PMN Number
    K160167
    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: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 04.038.000S LOT NUMBER: 6515P58 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 05/07/2023 MANUFACTURING SITE:JABIL BETTLACH EXPIRY DATE:01/06/2033 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 WITH THE TFNA FOR THE FEMORAL DIAPHYSEAL FRACTURE. THE END CAP IN QUESTION LOCKED WITH ABOUT 2 MM OF FLOATING. EVEN THOUGH THE SURGEON TRIED TO REDO IT AND RETIGHTENING THE LOCKING MECHANISM, IT DID NOT IMPROVE. THE PRIMARY SURGEON AND SENIOR PHYSICIAN DETERMINED THAT THE OPERATION WAS SECURELY TIGHTENED WITHOUT ANY ABNORMAL NOISES, SO THAT THE SURGERY WAS COMPLETED. THE ANGLE OF THE LAG SCREW WAS NOT BAD WHEN IT WAS INSERTED. THE SURGEON DID NOT REQUEST A PARTICULAR INVESTIGATION FOR THE CAUSE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA END CAP EXTENS. 0 TAN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043332 TFNA END CAP EXTENS. 0 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 6515P58 07611819648708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 10/130 DEG TI CANN TFNA 360/LEFT - SILE.| TFNA SCR PERF L85 TAN.| UNK - SCREWS: LAG.