BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAL ROD BENDER-LEFT FOR 5.5MM RODS

    MDR report key: 3081610 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11158
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    August 7, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT DEVELOPMENT EVALUATION SHOWED THIS ISSUE WAS PREVIOUSLY EVALUATED ON (B)(4) AND DEEMED VALID. (B)(4). IN CONCLUSION, THIS COMPLAINT IS DEEMED VALID FROM A DESIGN PERSPECTIVE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED FOR THIS ISSUE (B)(4).

    Additional Manufacturer Narrative · 1

    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 THE TIP OF THE CORONAL BENDER BROKE OFF WHILE BENDING THE COBALT CHROME ROD IN THE PATIENT. THE TIP OF THE BENDER WAS RETRIEVED AND THROWN AWAY. THE CASE WAS COMPLETED WITHOUT THE BENDERS. THE BROKEN CORONAL BENDER WILL BE RETURNED FOR INVESTIGATION. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185514 CORONAL ROD BENDER-LEFT FOR 5.5MM RODS HXW SYNTHES GMBH T953982

    Patients

    Seq Age Sex Outcome Treatment
    1