BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIPER

    MDR report key: 3035877 · Received February 20, 2013

    Report

    Report Number
    1719045-2013-10117
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 (B)(4) 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. DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE SUPPLIERS CERTIFICATION INDICATE THE CORRECT MATERIAL AND HARDNESS VALUES WERE OBTAINED. VISUAL INSPECTION OF THE CALIPER REVEALED THE GRADUATION MARKS ON THE SLIDER, THE CE MARK ON THE BODY AND THE HEAD OF THE SCREW ARE RUSTED. THE ETCHED LOGO, PART NUMBER AND LOT NUMBER ON THE BODY ARE NOT RUSTING. THE COMPONENTS IN QUESTION ARE PASSIVATED, THE SUPPLIER RECORDS INDICATE THESE PROCESSES WERE PERFORMED PER THE SYNTHES PROCEDURE. CONCLUSION: THE COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT BECAUSE PASSIVATION IS DEFINED AS A SPECIAL PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE CALIPER WAS FOUND RUSTED AT THE NUMBERS. CONSULTANT CHECKED THE SET AND ANOTHER CALIPER WAS FOUND RUSTED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74537 CALIPER KTZ SYNTHES MONUMENT 6280683

    Patients

    Seq Age Sex Outcome Treatment
    1