BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 95MM STERILE

    MDR report key: 6398467 · Received March 12, 2017

    Report

    Report Number
    3003506883-2017-10038
    Event Type
    Injury
    Date Received
    March 12, 2017
    Report Date
    February 16, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.295S LOT # H190345, RELEASE TO WAREHOUSE DATE: (B)(6) 2016, EXPIRATION DATE: 31 AUGUST 2026, MANUFACTURING SITE: (B)(6). 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 95MM 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 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. 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

    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 THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND CUT OUT. PATIENT WAS INITIALLY IMPLANTED WITH ONE TITANIUM (TI) CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL AND ONE TFNA HELICAL BLADE ON (B)(6) 2017 DUE TO AN INTERTROCHANTERIC HIP FRACTURE. THERE WERE NO REPORTED ISSUES DURING INITIAL SURGERY. PATIENT REPORTED PAIN ON UNKNOWN DATE AND RETURNED FOR A FOLLOW UP VISIT ON THE SAME WEEK AS THE REMOVAL SURGERY (EXACT DATE IS UNKNOWN). X-RAYS TAKEN DURING THE VISIT CONFIRMED THAT THE HELICAL BLADE CUT OUT OF THE SUPERIOR PART OF THE FEMORAL HEAD. PATIENT WAS REVISED ON (B)(6) 2017. ALL DEVICES WERE EASILY REMOVED AND WERE INTACT. NO DAMAGES TO THE DEVICES WERE OBSERVED. PATIENT WAS REVISED TO A COMPETITOR¿S TOTAL HIP IMPLANT. REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT REQUIRING MEDICAL INTERVENTION. NO SURGICAL DELAYS NOTED. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. ALL EXPLANTS WERE DISCARDED. SURGEON BELIEVES THAT DUE TO THE PATIENT POOR BONE QUALITY, THE HELICAL BLADE CUT OUT. SURGEON DOES NOT BELIEVE IT WAS DUE TO IMPLANT FAILURE. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICE REPORTED: 10MM/125 DEGREES TI CANNULATED TFNA 360MM/LEFT STERILE (PART# 04.037.027S, LOT# 9974120, QTY 1). THIS REPORT IS 1 OF 1 FOR: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180527 TFNA HELICAL BLADE 95MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA H190345

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention