BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7480843 · Received May 2, 2018

    Report

    Report Number
    2939274-2018-51971
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 11, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982095701
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH NOT AVAILABLE FOR REPORTING. DATE OF IMPLANT REPORTED ONLY AS 2017, EXACT DATE IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER TELEPHONE NOT AVAILABLE FOR REPORTING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 10-FEB-2017. EXPIRATION DATE: 31-DEC-2026 . PART #: 04.037.012S, LOT#: H290246 (STERILE) - 10MM/125 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.912.2 - LOCK PRONG, 125 DEGREE, TFNA BP-55 LOT - L238315, PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - H045953 , PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H242116, PART 21127 - RAW MATERIAL LOT BP-80 LOT - H145456. RAW MATERIAL RECEIVED FROM SUPPLIER METALWERKS PMD, INC. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS FOR TITANIUM MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, TFNA SCREW, AND 5.0MM LOCKING SCREW ON UNKNOWN DATE IN 2017. ON UNKNOWN DATE IT WAS REVEALED THE TFNA SCREW HAD CUT THROUGH THE LATERAL CORTEX OF THE FEMUR AS A RESULT OF A NON-UNION. THE CUT THROUGH RESULTED IN IRRITATION OF SOFT TISSUE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT WAS REVISED TO A TOTAL HIP CONSTRUCT. THIS REPORT IS FOR ONE (1) 10MM 1215 DEGREE CANNULATED TFNA NAIL 170MM THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323268 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.012S H290246 10886982095701

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention