BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 7385259 · Received March 30, 2018

    Report

    Report Number
    2939274-2018-51355
    Event Type
    Injury
    Date Received
    March 30, 2018
    Report Date
    March 2, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982095985
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 05/22/2015, EXPIRATION DATE: 04/30/2025 PART #: 04.037.042S, LOT#: 9816391 (STERILE) - 10MM/130 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - 9338708. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7840768. PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - 7963420. PART 21127 - RAW MATERIAL LOT BP-80 LOT - 7854209. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(6) COMPANY. CERTIFIED TEST REPORT RECEIVED FROM (B)(6) FOR TITANIUM AND CERTIFICATE OF TEST FOR TITANIUM INGOT RECEIVED FROM ALCOA MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUT AWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION 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.¿ THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE IS NOT KNOWN. DATE OF IMPLANT IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A LEFT TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) AND TFNA HELICAL BLADE ON UNKNOWN DATE. ON UNKNOWN DATE, IT WAS DETERMINED THE NAIL WAS BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE NAIL AND BLADE. IT WAS REPORTED SURGEON HAD SOME DIFFICULTY REMOVING THE BLADE DUE TO THE BROKEN NAIL. AS A RESULT, SURGERY WAS DELAYED APPROXIMATELY 10 MINUTES. PATIENT WAS REVISED TO A 95 DEGREE CONDYLAR PLATE. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE 95MM (04.038.295, LOT 9835750, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM 130 DEGREE TITANIUM CANNULATED TFNA NAIL 170MM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230113 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.042S 9816391 10886982095985

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention