BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL

    MDR report key: 3161403 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03057
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    January 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    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. (B)(6). THE PRESENT DEVICES WERE ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. A FUNCTION TEST HAS SHOWN THAT THESE DEVICES ARE NOT FUNCTIONAL AS REQUIRED ANYMORE. THIS IS CAUSED BY SOME STRONG STRESS MARKS AT THE SPIRAL INSERTER AND AT THE CONNECTING SCREW. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THESE STRESS MARKS. WE CAN ONLY ASSUME THAT INTENSE USE IN COMBINATION WITH WEAR AND TEAR CAUSED THIS OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN SURGERY AS THE SURGEON WAS INSERTING THE THIRD RAFN NAIL, THE SURGEON WANTED TO INSERT A BLADE. THE SURGEON HAD DIFFICULTIES WITH INSERTION SYSTEM. THE CONNECTING SCREW OF THE BLADE DOES NOT GO IN THE SPIRAL INSERTER FOR SPIRAL BLADE INSERTION AND IT IS DIFFICULT TO INSERT IN THE AIMING ARM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263110 AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL FZX SYNTHES GMBH 1714075

    Patients

    Seq Age Sex Outcome Treatment
    1