BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L80 TAN

    MDR report key: 6517606 · Received April 24, 2017

    Report

    Report Number
    9612488-2017-10189
    Event Type
    Injury
    Date Received
    April 24, 2017
    Report Date
    April 3, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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). 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE REPORTED SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: DEC 21, 2016. EXPIRATION DATE: DEC 1, 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT LOT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. (B)(4). 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 THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE CUT OUT POSTOPERATIVELY. THE PFNA BLADE AND NAIL WERE INITIALLY IMPLANTED ON (B)(6) 2017 TO TREAT A TROCHANTERIC FEMORAL FRACTURE. ON (B)(6) 2017, IT WAS DISCOVERED THAT THE BLADE HAD CUT OUT. THE SURGEON COMMENTED THAT THE REASON THE BLADE CUT OUT IS THAT ¿HE INSERTED THE BLADE AHEAD¿ (TOO FAR) AND THAT THIS WAS A TECHNICAL ERROR ON HIS PART. REVISION SURGERY INCLUDING TOTAL HIP ARTHROPLASY WILL BE PLANNED. CONCOMITANT MEDICAL PRODUCTS: PFNA NAIL, PART: 472.101S, LOT: L210177, QUANTITY: 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298777 PFNA-II BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH L237428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 472.101S, PFNA NAIL, QTY 1