BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD HOLDER

    MDR report key: 3320276 · Received August 30, 2013

    Report

    Report Number
    1719045-2013-01923
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Report Date
    August 7, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INSTRUMED MANUFACTURED THE ROD INTRODUCER ASSEMBLY, PART NUMBER 03.616.048, AND LOT NUMBER 6970076. THE MATERIALS OF THE BENT COMPONENT AND BROKEN KNOB WERE CONFIRMED TO BE CORRECT; HOWEVER THE HEAT TREAT VALUE COULD NOT BE VERIFIED DUE TO THE WALL THICKNESS OF THE COMPONENT. THE PARTS OF THIS LOT WERE INSPECTED FOR FUNCTIONAL REQUIREMENTS AT 100% AND FOUND CONFORMING TO ALL REQUIRED SPECIFICATIONS AT SYNTHES INCOMING FINAL INSPECTION. DUE TO DAMAGE, THESE FUNCTIONAL REQUIREMENTS COULD NOT BE VERIFIED DURING EVALUATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A LOCKING MECHANISM DID NOT LOCK RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429191 ROD HOLDER LXH SYNTHES MONUMENT 6970076

    Patients

    Seq Age Sex Outcome Treatment
    1