BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3000824 · Received March 12, 2013

    Report

    Report Number
    8030965-2013-10459
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    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 PRODUCT EVALUATION VISUAL INSPECTION REVEALED THE TANG WAS BROKEN OFF THE RETURNED PART. A CAPA WAS CREATED AND A DESIGN CHANGE WAS MADE TO ADDRESS THIS ISSUE. THIS HANDLE WAS MADE PRIOR TO THE DESIGN CHANGE AND PRIOR COMPLAINTS WERE DISPOSITIONED VALID FOR THIS CONDITION SO THIS IS VALID, AND THE REQUIRED CORRECTIVE ACTION HAS BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIPPLE ON THE INSERTION HANDLE HAD BEEN SNAPPED OFF. THE SALES CONSULTANT DOESN'T KNOW HOW OR WHEN IT HAPPENED. THE SURGEON USED A BACKUP HANDLE FOR THE PROCEDURE.

    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
    103700 STANDARD INSERTION HANDLE LXH SYNTHES USA 1565420

    Patients

    Seq Age Sex Outcome Treatment
    1