BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L85 TAN

    MDR report key: 3174428 · Received June 18, 2013

    Report

    Report Number
    8030965-2013-03475
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE PFNA-II BLADE SHOWS GRINDING MARKS ON THE OUTSIDE SURFACE AND ON THE TIP ONE EDGE IS BROKEN AWAY. THIS DAMAGE DOES NOT AFFECT THE FUNCTION OF THE BLADE. IT IS POSSIBLE THAT ONE OF THE FOLLOWING POINTS COULD HAVE LEAD TO THE DAMAGES ON THE BLADE: THE BLADE WAS NOT CORRECT MOUNTED ON THE INSERTER. AFTER INSERTION IN TO THE BONE THE INSERTER WAS UNLOCKED OFF THE BLADE TOO EARLY. THE BLADE WAS NOT OPERATED AS DESCRIBED IN THE OPERATION GUIDE. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE PATIENT HAD A FEMORAL TROCHANTERIC FRACTURE. THE INSERTER DID NOT LOCK THE BLADE. IN THE HOSPITAL WITH OVER 130 OPERATIONS OF JPA, THE ADVERSE EVENT OF UNLOCKING OF THE BLADE HAPPENED. THE SALES REP DID NOT ATTEND THE OPERATION. IT WAS NOTED: THE OPERATION SUCCEEDED BY HAMMERING OF THE BLADE FITTING INTO THE INSERTER, HOWEVER, THE SURGEON FOUND THERE WAS A SPACE IN X-RAY IMAGE WHEN THE BLADE WAS LOCKED, THE INSERTER ROTATED FREE. THE SURGEON COULD CHOOSE THE USAGE OF JPA HOLLOW DRIVER IN ORDER TO LOCK IT; HOWEVER HE USED ANOTHER PRODUCT WITHOUT SUCH A CHOICE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275345 PFNA-II BLADE L85 TAN LXT SYNTHES GMBH 8355251

    Patients

    Seq Age Sex Outcome Treatment
    1