BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN® SRS® BONE VOID FILLER ROTARY MIX 5CC-STERILE

    MDR report key: 3071764 · Received April 22, 2013

    Report

    Report Number
    2939274-2013-10009
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES NORIAN
    Product Code
    MQV
    PMA / PMN Number
    K060408
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THE UNIT IN QUESTION WAS RETURNED. THE CLIP WAS REMOVED FROM THE ROTARY MIXER ASSEMBLY, AND THE ROTARY CHAMBER CONTAINED WHAT APPEARED TO BE CURED (MIXED) NORIAN PRODUCT. THE TRANSFER SYRINGE APPEARED TO BE EMPTY. MUCH OF THE ORIGINAL PACKAGING WAS PRESENT AND INTACT (TRAY, TRAY LID, CARDBOARD INSERT, DFU INSERT, SALES UNIT CARTON). THE SOLUTION SYRINGE WAS PRESENT AND EMPTY. THE SOLUTION SYRINGE PLUNGER WAS IN THE FORWARD POSITION. THE CAP HAD BEEN REMOVED FROM THE ROTARY CHAMBER. THE TRANSFER SYRINGE PLUNGER WAS COMPLETELY EXTENDED (SYRINGE CHAMBER OPEN). THE COMPLAINT STATES THAT THE PRODUCT DID NOT MIX PROPERLY. ALTHOUGH THERE APPEARS TO BE MIXED MATERIAL IN THE ROTARY CHAMBER, THERE IS NO WAY TO DETERMINE WHETHER OR NOT THE MATERIAL MIXED PROPERLY. THIS COMPLAINT IS INDETERMINATE. PLACEHOLDER.

    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. ORIGINAL AWARENESS DATE IS (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL PLATEAU PROCEDURE, A 5CC PACKAGE OF NORIAN BONE VOID FILLER FOR THE ROTARY MIXER WAS PLACED IN THE MIXER BUT DID NOT MIX PROPERLY. THE PRODUCT WAS UNUSABLE. ANOTHER 5CC PACKAGE WAS USED, IT MIXED WELL, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172800 NORIAN® SRS® BONE VOID FILLER ROTARY MIX 5CC-STERILE MQV SYNTHES NORIAN N000338

    Patients

    Seq Age Sex Outcome Treatment
    1