BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L90 TAN

    MDR report key: 4143114 · Received October 6, 2014

    Report

    Report Number
    9612488-2014-10428
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: IMPLANT DATE: (B)(6) 2014. THE PART WAS RECEIVED INTACT. UPON INVESTIGATION, THE BLADE HAD NO EFFECT ON THE NAIL FRACTURE. 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. 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 THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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: IT WAS REPORTED THAT THE EVENT TOOK PLACE APPROXIMATELY FIVE MONTHS POST OPERATIVELY ON AND (B)(6) 2014. NOW THE NAIL IS BEND OR BROKEN IN THE PROXIMAL PART, FROM THE BLADE HOLE AND UP. THE SURGEON IS NOT SURE IF IT IS BROKEN OR BENT BUT WANTED TO REPLACE IT WITH A NEW PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) LONG. THERE WERE NO REPORTS OF A SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624711 PFNA BLADE PERF L90 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH 8540535

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR