BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 105MM STERILE

    MDR report key: 6414673 · Received March 17, 2017

    Report

    Report Number
    3003506883-2017-10039
    Event Type
    Injury
    Date Received
    March 17, 2017
    Report Date
    February 23, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED ON UNKNOWN DATE AT A DIFFERENT FACILITY. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL DEVICES REPORTED: TROCHANTERIC FEMORAL NAIL-ADVANCED, LEFT (PART NUMBER 04.037.042S, LOT NUMBER H208200, QUANTITY 1) LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.305S LOT # 7954874. RELEASE TO WAREHOUSE DATE: 31 MARCH 2015. EXPIRATION DATE: 28 FEBRUARY 2025. MANUFACTURING SITE: (B)(4). 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 105 MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE (B)(4) MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS (B)(4) 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. 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 IS REPORTED PATIENT WAS IMPLANTED ON UNKNOWN DATE AT A DIFFERENT FACILITY WITH A LEFT TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA), HELICAL BLADE, AND LOCKING SCREW. ON UNKNOWN DATE PATIENT REPORTED PAIN. X-RAY TAKEN ON UNKNOWN DATE REVEALED THE HELICAL BLADE HAD MIGRATED THROUGH THE FEMORAL HEAD INTO THE ACETABULUM AND PELVIS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED ALL HARDWARE AND REVISED PATIENT TO A TOTAL HIP CONSTRUCT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. THIS COMPLAINT IS FOR 1 DEVICE. CONCOMITANT DEVICES REPORTED: TROCHANTERIC FEMORAL NAIL-ADVANCED, LEFT (PART NUMBER 04.037.042S, LOT NUMBER H208200, QUANTITY 1) LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196421 TFNA HELICAL BLADE 105MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 7954874

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention