BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3062966 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10666
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    May 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE FIRST TWO THREADS ON THE DISTAL END OF THE HOLDING SLEEVE ARE BROKEN OFF. THE REMAINING THREADS DO NOT EXHIBIT ANY DAMAGE. THE BROKEN FRAGMENT IS STILL IN THE THREADS OF THE SCREW THAT WAS ALSO RETURNED ON THIS COMPLAINT. THE CONDITION APPEARS TO BE THE RESULT OF THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE THE THREADED TIP OF THE MATRIX HOLDING SLEEVE BROKE OFF INTO THE SCREW. THE SURGEON REMOVED THE SCREW AND ALL FRAGMENTS AND COMPLETED THE CASE WITHOUT HARM TO THE PATIENT.

    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
    166032 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6602185

    Patients

    Seq Age Sex Outcome Treatment
    1