BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 3130670 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02350
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWA
    Product Problem
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INSTRUMENT WAS SENT TO OUR RELEVANT PM FOR INVESTIGATION: THE RETURNED ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORD HAS BEEN RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6 )AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE PROXIMAL FEMORAL NAIL A (PFNA) BLADE STUCK TO THE BLADE INSERTER. THE SURGEON FOUND IT DIFFICULT TO LOCK THE BLADE AND RELEASE THE INSERTER. THE SURGEON DECIDED TO TAKE OUT THE BLADE AND PUT IN A NEW ONE. IT WAS REPORTED THAT BECAUSE THE SURGEON WAS UNABLE TO RELEASE THE BLADE FROM THE INSERTER, HE DECIDED TO BREAK THE BLADE TO GET THE INSERTER FREE. THE TIP OF THE BLADE REMAINED ATTACHED TO THE INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232905 IMPACTOR F/PFNA BLADE HWA SYNTHES GMBH 8135485

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR