BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 3023528 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-10577
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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. THE DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE FOLLOWING FACTORS HAVE NOT CONTRIBUTED TO OR CAUSED THE EVENT DESCRIBED IN THE COMPLAINT: DEVICE DESIGN, PROCESSING SPECIFICATIONS, MATERIAL, PACKAGING, TOLERANCE STACK-UP/MATING PARTS, STERILIZATION, LABELING, AND USER TECHNIQUE. A PART OF THE SPRING IS BROKEN OFF AND WAS NOT SENT BACK FOR INVESTIGATION. THE UPPER PART OF THE CUTTING MECHANISM IS BROKEN OFF AND ENCLOSED. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEMONSTRATION THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WOULD NOT TENSION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125636 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX JDQ SYNTHES GMBH 7516728

    Patients

    Seq Age Sex Outcome Treatment
    1