BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE PERF L75 SST

    MDR report key: 3130601 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02803
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 A BLADE (PFNA-BLADE) COULD NOT BE LOCKED DURING SURGERY ON (B)(6) 2013. THE INSERTION INSTRUMENT COULD BE REMOVED FROM THE BLADE BUT IT DID NOT LOCK THE BLADE AND THE BLADE STAYED UNLOCKED IN THE NAIL/BONE OF THE PATIENT. THE 1ST BLADE WAS REMOVED AND THE SAME PROCEDURE WAS DONE WITH A NEW BLADE WITH THE SAME RESULT. THE BLADE WAS THEN LEFT UNLOCKED IN THE NAIL/BONE AND THE SURGERY WAS TERMINATED. THE SURGERY WAS DELAYED BY A LARGE, UNKNOWN AMOUNT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231728 PFNA BLADE PERF L75 SST HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention