BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCER

    MDR report key: 3051859 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10651
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    October 6, 2011
    Report Date
    October 6, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    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

    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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THAT THE DEVICE WAS RETURNED WITH THE SPRING MISSING FROM THE ASSEMBLY. THE MISSING SPRING DOES NOT AFFECT THE FUNCTION AS NOTED IN THE COMPLAINT DESCRIPTION. IT WAS FOUND THAT A RIVET WAS MISSING AT THE PROXIMAL END OF THE INSTRUMENT. THERE ARE WITNESS MARKS INDICATING THE RIVET WAS ASSEMBLED AT ONE TIME. THIS DOES NOT AFFECT THE COMPLAINT CONDITION. THE TIP OF THE INSTRUMENT HAS SCRATCHES AND DENTS. THE FUNCTIONAL TESTS PERFORMED PASS INSPECTION REQUIREMENTS AS PROVIDED ON THE INSPECTION SHEET AT THE TIME OF MANUFACTURE. THE COMPLAINT CONDITION CANNOT BE DUPLICATED. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CADAVER LAB, IT WAS NOTED THAT THE ROD INTRODUCER RECEIVED FROM THE EVALUATIONS DEPARTMENT ((B)(4)) WOULD NOT HOLD THE ROD TIGHT WHEN MANEUVERING FOR PLACEMENT. ALSO NOTED WAS AN UNRELATED MISSING RIVET ON THE PROXIMAL END OF THE BARREL AND HAS NO EFFECT ON THE HOLDING ABILITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153478 ROD INTRODUCER LXH SYNTHES MONUMENT 6486626

    Patients

    Seq Age Sex Outcome Treatment
    1