BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 12461580 · Received September 13, 2021

    Report

    Report Number
    8030965-2021-07667
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 16, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819649460
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: EXACT DATE OF EVENT IS UNKNOWN. EVENT OCCURRED SOMETIME BETWEEN WHEN THE DEVICE WAS IMPLANTED ON (B)(6) 2021 AND WHEN THE FRACTURE WAS CONFIRMED ON (B)(6) 2021. OCCUPATION: INITIAL REPORTER IS A SYNTHES SALES REPRESENTATIVE. PART 04.037.012S, LOT 50P4325: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: APRIL 10, 2020. EXPIRATION DATE: MARCH 02, 2030. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PHOTO INVESTIGATION WAS COMPLETED: A VISUAL INSPECTION OF THE DEVICE FROM THE PROVIDED X-RAYS WAS PERFORMED; NO ISSUES WERE IDENTIFIED IN THE X-RAYS. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY FOR THE TROCHANTERIC FEMUR OCCULT FRACTURE WITH THE TROCHANTERIC FIXATION NAIL-ADVANCE (TFNA) IMPLANT. AFTER THE SURGERY, A FEMORAL NECK FRACTURE WAS CONFIRMED BY X-RAY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY REMOVING THE TFNA IMPLANTS AND PERFORMING BIPOLAR HIP ARTHROPLASTY (BHA) SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A TFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359186 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 50P4345 07611819649460

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKSCR Ø5 L36 F/NAILS TAN| TFNA HELICAL BLADE PERF L85 TAN