BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 105MM STERILE

    MDR report key: 6341558 · Received February 17, 2017

    Report

    Report Number
    3003506883-2017-10021
    Event Type
    Injury
    Date Received
    February 17, 2017
    Report Date
    January 24, 2017
    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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: SEP 8, 2015. EXPIRATION DATE: AUG 1, 2025. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 105MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS 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. 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). 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

    A PRODUCT INVESTIGATION WAS COMPLETED: PRODUCT 04.038.305S WITH LOT 9870334 WAS NOT RETURNED. COMPLAINED ISSUE (THE BLADE PENETRATED ACETABULAR ROOF) COULD BE CONFIRMED BASED ON THE PROVIDED X-RAYS. ROOT CAUSE COULD NOT BE DEFINED DUE THE DEVICE NOT BEING RETURNED. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017 THE SURGEON FOUND THAT THE TROCHANTERIC FIXATION NAIL ¿ ADVANCED (TFNA) HELICAL BLADE HAD PENETRATED THE ACETABULAR ROOF. THE PATIENT IS HAVING DIFFICULTY WALKING. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016 TO TREAT A TROCHANTERIC FRACTURE. DUE TO THE REPORTED EVENT, REVISION SURGERY INCLUDING A TOTAL HIP ARTHROPLASTY IS PLANNED. IT IS NOT KNOWN ON WHAT DATE THE REVISION SURGERY IS SCHEDULED FOR. CONCOMITANT MEDICAL PRODUCTS: 1X 04.005.530S / 9882724 (LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN); 1X 04.037.912S / 9962895 (TFNA FEM NAIL Ø9 125° L170 TIMO15); 1X 04.038.000S / 9347629 (TFNA END CAP EXTENS. 0 TAN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123600 TFNA HELICAL BLADE 105MM STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9870334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.005.530S, 5.0MM TI LOCKING SCREW 40MM, QTY 1| 04.037.912S, 9MM/125 DEG TI CANN TFNA 170MM, QTY 1| 04.038.000S, TI END CAP FOR TFNA 0MM EXTN, QTY 1