BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE

    MDR report key: 3081117 · Received April 26, 2013

    Report

    Report Number
    1719045-2013-10802
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    November 14, 2011
    Report Date
    November 14, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    K071046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS 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 DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE PRODUCT EVALUATION AND VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE EVENT DESCRIPTION AND REVEALED THAT THE PULL STRIP WAS OPENED UP AND THE BOX WAS DENTED, AS IF IT WAS STEPPED ON. THE STERILE PEEL-POUCH DID NOT APPEAR TO HAVE BEEN BREACHED. RISK ASSESSMENT - NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED. WHILE THE FOIL LAYER APPEARED TO HAVE BEEN LEFT UNAFFECTED, IT WAS DECIDED NOT TO USE THE PRODUCT AND TO REMOVE IT FROM THE HOSPITAL. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    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 SALES CONSULTANT RECEIVED A CHRONOS BETA-TCP, TRI CALCIUM PHOSPHATE, STRIP. THE PULL STRIP ON THE OUTER PACKAGING WAS NOT SEALED AND THE SALES CONSULTANT IS CONCERNED THAT THE STERILITY MAY BE COMPROMISED. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182256 CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE MQV SYNTHES MONUMENT N000943

    Patients

    Seq Age Sex Outcome Treatment
    1