BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L110 TAN

    MDR report key: 4222767 · Received November 4, 2014

    Report

    Report Number
    9612488-2014-10484
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. 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 REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE DID NOT LOCK. IT WAS REPORTED THAT THE BLADE HAD TO BE REMOVED BLADE AND ANOTHER BLADE HAD TO BE USED, WHICH WORKED NORMALLY. SURGERY WAS REPORTED TO BE PROLONGED ABOUT 20 MINUTES. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707217 PFNA BLADE PERF L110 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH 9089946

    Patients

    Seq Age Sex Outcome Treatment
    1