BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR LISS INSERTION GUIDE-LEFT

    MDR report key: 3010237 · Received March 19, 2013

    Report

    Report Number
    8030965-2013-10527
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    August 30, 2011
    Report Date
    August 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PART WAS RECEIVED IN 2 PIECES, THE MAIN COMPONENT AND THE RADIOLUCENT EXTENSION. THE CONNECTING SCREW WAS MISSING AND WAS NOT RETURNED. THE RADIOLUCENT EXTENSION WAS FADED AND SHOWED SIGNS OF EXTENSIVE USE. THE MAIN COMPONENT HAD NICKS IN THE ANODIZE COATING AROUND WHERE IT MATES WITH THE PLATES. THE PIECES COULD BE ASSEMBLED EASILY BUT THE CONNECTING SCREW WAS NOT RETURNED TO HOLD THEM TOGETHER. THERE IS NOTHING TO INDICATE A DESIGN OR MANUFACTURING RELATED ISSUE BUT SINCE THE SCREW WAS NOT RETURNED FOR EVALUATION, THE COMPLAINT IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE CONNECTING SCREW ON THE DISTAL FEMUR LISS INSERTION GUIDE BROKE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114721 DISTAL FEMUR LISS INSERTION GUIDE-LEFT FZX SYNTHES GMBH 2090897

    Patients

    Seq Age Sex Outcome Treatment
    1