BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREW FOR PFNA BLADE

    MDR report key: 3171571 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02700
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    February 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. OUR INVESTIGATIONS HAVE SHOWN THAT THE END CAP DID NOT PULL BACK THE COVER OF THE PFNA BLADE. THIS CAUSED THE JAM AND MADE THE CONNECTION BETWEEN BLADE AND INSTRUMENT UNSTABLE. THE REASON FOR THIS FAILURE IS UNDETERMINED, HOWEVER IT IS POSSIBLE TOO MUCH MECHANICAL FORCE WAS APPLIED DURING THE MOUNTING OF THE INSTRUMENT WITH THE PFNA-BLADE. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOWED CONFORMITY WITH THE SPECIFICATIONS. THE EXACT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS DEEMED VALID, A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Description of Event or Problem · 1

    BLADE BLOCKED WITH THE EXTRACTION SCREW. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272583 EXTRACTION SCREW FOR PFNA BLADE HWB SYNTHES GMBH 2119302

    Patients

    Seq Age Sex Outcome Treatment
    1