BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTSCR F/PFNA BLADE

    MDR report key: 3123823 · Received May 22, 2013

    Report

    Report Number
    8030965-2013-02308
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    January 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE RETURNED DEVICE WAS ABLE TO BE DISASSEMBLED USING THE RELEVANT IMPLANT REMOVAL TECHNIQUE. THE INVESTIGATION DETERMINED THAT THE BLADE MAY HAVE BEEN TIGHTENED TOO MUCH CAUSING THE DEVICE TO JAM. VISUAL INSPECTION NOTED THE EXTRACTION INSTRUMENT WAS SLIGHTLY DAMAGED AND HAD VISIBLE ORGANIC RESIDUES. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. THE INVESTIGATION DETERMINED THE EVENT TO BE INDETERMINATE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Additional Manufacturer Narrative · 1

    PREVIOUS INITIAL (B)(4) WAS SUBMITTED IN ERROR SINCE (B)(4) IS A DUPLICATE OF (B)(4).

    Description of Event or Problem · 1

    EXISTING PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE WAS REMOVED FROM THE PATIENT WITH THE EXTRACTION SCREW FOR PFNA BLADE. THE SURGEON WAS NOT ABLE TO DISCONNECT THE BLADE FROM THE EXTRACTION SCREW IN THE STERILE FIELD. CONSEQUENTLY THE PFNA BLADE IS STILL ATTACHED TO THE EXTRACTION SCREW OF PFNA BLADE. THIS IS REPORT 1 OF 1 FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225795 EXTRACTSCR F/PFNA BLADE GFA SYNTHES GMBH 2617584

    Patients

    Seq Age Sex Outcome Treatment
    1