BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 3183619 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03932
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    December 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE ADDITIONAL EVALUATION REVEALED THAT THE PRESENT DEVICES WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. THERE ARE HEAVY STRESS MARKS ALL OVER THE BLADE AND THE FIRST THREAD FLANK OF THE INTERNAL LOCKING SCREW IS DAMAGED, WHICH INDICATES EXCESSIVE USE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BUT AS THERE WERE NO DETAILS ABOUT THE EVENT PROVIDED WE ARE NOT ABLE TO DETERMINE HOW OR WHEN THESE DAMAGES OCCURED AND IN WHICH RELATION THEY ARE WITH THE BLOCKING OF THE BLADE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BLOCKED ON THE IMPACTOR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284418 IMPACTOR F/PFNA BLADE GFA SYNTHES GMBH 2217128

    Patients

    Seq Age Sex Outcome Treatment
    1