BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX THREADED PERSUADER- STANDARD

    MDR report key: 3033225 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-10498
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    May 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(4)

    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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS (DHR) REVEALED THAT THE MATRIX THREADED PERSUADER WAS MANUFACTURED BY MAGNUM MANUFACTURING. ONE NONCONFORMANCE WAS FOUND FOR FUNCTIONAL ISSUES (HANDLE WILL NOT COME OUT). THE NONCONFORMING PARTS WERE SHIPPED BACK TO THE SUPPLIER FOR EVALUATION AND REWORK, AND THE NONCONFORMANCE WAS CLOSED. RELEVANCE TO THE COMPLAINT CONDITION COULD NOT BE DETERMINED. ALL PARTS WERE MADE TO THE CORRECT MATERIAL REQUIREMENTS, MET THE HARDNESS AND REQUIRED SPECIFICATIONS. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER THREADED SLEEVE OF THE MATRIX THREADED PERSUADER BROKE OFF. IT IS UNKNOWN WHEN AND HOW THE INSTRUMENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136235 MATRIX THREADED PERSUADER- STANDARD LXH SYNTHES MONUMENT 6390308

    Patients

    Seq Age Sex Outcome Treatment
    1