BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L85 TAN

    MDR report key: 2882944 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01626
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE DEVICE PASSED THE REQUIRED FUNCTIONAL TEST SUCCESSFULLY. THE FAILURE AS PER EVENT DESCRIPTION COULD NOT BE DUPLICATED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PFNA-II BLADE FAILED TO LOCK INTRAOPERATIVELY. THE SURGEON FOLLOWED THE SURGICAL STEPS AND CHECKED THE POSITION OF THE GUIDE WIRE FOR BLADE INSERTION. THE SURGEON THEN ASSEMBLED THE BLADE HIMSELF. THE BLADE WAS IMPACTED INTO THE EXPECTED POSITION. WHEN THE SURGEON TRIED TO LOCK THE BLADE, IT WAS NOTED THE SLEEVE DID NOT ADVANCE TO THE TIP OF THE BLADE. THE SURGEON REVIEWED THE X-RAY AND NOTED THE GAP BETWEEN THE SLEEVE AND BLADE WAS NOT CLOSE. THE OPERATING ROOM WAS ADVISED TO REMOVE AND EXCHANGE THE BLADE IF THE BLADE FAILS TO LOCK. THE SURGEON REMOVED THE BLADE. REPORTEDLY THE BLADE WAS ENGAGED TO THE IMPACTOR AND COULD NOT BE HAMMERED OUT AS EASY AS THE EXTRACTOR. THE SURGEON PROCEEDED TO HANDLE WITH CARE. THE REMOVAL OF THE BLADE TOOK ABOUT HALF AN HOUR. THE BLADE WAS EXCHANGED WITH ANOTHER BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA-II BLADE L85 TAN PFNA-II BLADE KTT SYNTHES GMBH 8015661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention