BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 85MM STERILE

    MDR report key: 5812014 · Received July 21, 2016

    Report

    Report Number
    3003506883-2016-10124
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 16, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART: 04.038.285S LOT: 9955104, PART MFG. DATE: 12 JANUARY 2016 PART EXP. DATE: 01 JANUARY 2026 DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 85MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMITIES NOTED. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(4). DEVICE 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

    PATIENT INFORMATION IS UNKNOWN. UDI: (B)(4). EXPLANT DATE: DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER PHONE NUMBER: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY FOR INTERTROCHANTERIC FEMORAL FRACTURE ON (B)(6) 2016, THE SURGEON PALPATED THE FRACTURED PART FROM THE INCISIONAL PART AND CONFIRMED THAT CALCAR OF THE FEMORAL TROCHANTER WAS REDUCED TO A POSITION WHERE THE FRACTURED BONE ATTACHED TO THE OTHER SITE OF THE BONE. ON (B)(6) 2016, IT WAS NOTED EXCESS SLIDING OF THE REPORTED TITANIUM TROCHANTERIC FIXATION NAIL ADVANCED (TFN-A) HELICAL BLADE WAS DETECTED. THE SURGEON INDICATED THAT THE FEMORAL HEAD MIGHT ROTATE AND THE ROTATING COULD HAVE LED TO THE EXCESS SLIDING FROM THE REDUCED POSITION. IN ADDITION, THE SURGEON COMMENTED THAT TFN-A BLADES WERE STABLE TO ROTATE AND ROTATING RIGHT AFTER INTERNAL FIXING OF THE HUMERAL HEAD WAS UNUSUAL; THEREFORE, THE SURGEON FELT THAT THE LOCKING STRUCTURE MAY NOT HAVE STAYED LOCKED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466018 TFNA HELICAL BLADE 85MM STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9955104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention