BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 3961400 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12857
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    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. ADDITIONAL COMMON DEVICE NAME: HWC. THE LOT NUMBER REPORTED IN THE COMPLAINT REPORT IS UNABLE TO BE VERIFIED, LOT 8953462. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE BLADE MISALIGNED WITH THE NAIL DURING INSERTION AND PART OF THE BLADE WAS CHIPPED. THE SURGERY WAS COMPLETED WITH A DIFFERENT BLADE WITH A REPORTED DELAY OF 5 MINUTES. THE BROKEN PIECE OF THE DEVICE MAY HAVE REMAINED IN THE PATIENT BODY. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438197 PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES (USA) 8953492

    Patients

    Seq Age Sex Outcome Treatment
    1