BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II Ø10 LONG LE 125° L280 TAN

    MDR report key: 3884884 · Received June 19, 2014

    Report

    Report Number
    9612488-2014-10237
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 24, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE CODE, HSB. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION AND SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE (B)(4) PROXIMAL FEMORAL NAIL WAS USED IN THE THIGHBONES FRACTURE CASE. AT THE STAGE OF INSERTING THE NAIL, THE LEFT AND RIGHT THIGHBONES NAIL AND RIGHT NAIL WERE MISTAKENLY SWAPPED AND IMPLANTED. NO ONE NOTICED THIS MISTAKE UNTIL LATER ON WHEN THE PATIENT COMPLAINED OF PAIN IN THE FRONT OF THE THIGHBONES. UPON THE PATIENT¿S CLAIM, AN X-RAY WAS TAKEN AND THIS MISTAKE WAS FOUND. THE SURGEON CLAIMS THAT THE DESCRIPTION OF THE PACKAGE OF THE NAILS (LEFT/RIGHT) IS UNCLEAR AND REQUESTS IMPROVEMENT OF THE PRODUCT TO PREVENT SUCH MISTAKES IN THE FUTURE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359892 PFNA-II Ø10 LONG LE 125° L280 TAN SCREW, FIXATION, BONE HWC SYNTHES BETTLACH 2791130

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention