BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 320MM/LEFT - STERILE

    MDR report key: 19696202 · Received July 8, 2024

    Report

    Report Number
    8030965-2024-08347
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 4, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819650053
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    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. ADDITIONAL NARRATIVE: D2: ADDITIONAL PROCODE: KTT E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H6: PART: 04.037.053S LOT: 9864819 MANUFACTURING SITE: WERK VILLMERGEN LOGISTIK RELEASE TO WAREHOUSE DATE: 22 JULY 2015 EXPIRATION DATE: 01 JULY 2025 SUPPLIER: (B)(4) A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE TFNA FEM NAIL Ø10 LE 130° L320 TIMO15 EXHIBITS A BROKEN CONDITION AT THE TRANSVERSE HOLE. ADDITIONALLY THE IMPLANT WAS OBSERVED DISCOLORATION AND SCRATCHES IN VARIOUS PARTS OF THE DEVICE. THIS MAY BE DUE TO THE EXTRACTION PROCESS. BASED ON THE PROVIDED INFORMATION, WE CANNOT DETERMINATE THE EXACT CAUSE OF THIS BREAKAGE. WHILE NO ROOT CAUSE CAN BE ESTABLISHED WITH THE AVAILABLE INFORMATION, FACTORS SUCH AS THE AGE OF THE PATIENT, UNDERLYING DISEASE, BONE DENSITY, OR A POSSIBLE EARLY WEIGHT-BEARING, COULD HAVE LED TO FAILURE OF THE IMPLANT. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. A FUNCTIONAL EVALUATION WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE TFNA FEM NAIL Ø10 LE 130° L320 TIMO15 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. 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 ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. ON (B)(6) 2024, THE PATIENT REPORTED FEELING DISCOMFORT AND UPON EXAMINATION, IT WAS FOUND THAT THE NAIL HAD BROKEN OFF NEAR THE BLADE HOLE. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED. THE BROKEN NAIL WAS REMOVED, AND REFIXATION USING TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANTS AND CEMENT WAS DONE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS STABLE. THE SURGEON COMMENTED AS FOLLOWS: BONE UNION HAS NOT BEEN ACHIEVED. THERE IS ALSO SUSPICION OF INFECTION. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 320MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142559 10MM/130 DEG TI CANN TFNA 320MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 9864819 07611819650053

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE| UNK - SCREWS: LOCKING