BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAL ROD BENDER-RIGHT FOR 5.5MM RODS

    MDR report key: 3062951 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10874
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    September 6, 2011
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 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. PRODUCT DEVELOPMENT EVALUATION REVEALS THE PART WAS RECEIVED WITH THE TIP OF THE BENDER BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. THE BREAK IS ON THE TIP CLOSEST TO THE HANDLE AND IS WHERE THE SLOT TRANSITIONS TO THE RADIUS THAT FITS AROUND THE ROD WHEN IN USE. NO OTHER DAMAGE IS EVIDENT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS ISSUE WAS PREVIOUSLY EVALUATED DEEMED VALID. PREVIOUS EVALUATION NOTES, THE FAILURE MODE AND LOCATION OF FAILURE WERE DUPLICATED WHEN BENDING MATRIX 5.5 MM WARM-WORKED CO-CR RODS. MATERIAL ANALYSIS PERFORMED ON THE RETURNED PART INDICATED THAT THE PROCESS OF WELDING MATERIAL AROUND THE PERIMETER OF THE ROD SLOT IS CREATING AN AS-CAST CONDITION IN THE WELDED MATERIAL AND INCREASED CARBIDE FORMATION IN THE SURROUNDING SUBSTRATE. IN RESPONSE TO THESE COMPLAINTS, IMPROVEMENTS WERE IDENTIFIED AND IMPLEMENTED. AN INTERNAL ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    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 DURING A FUSION PROCEDURE AT T3-PELVIS, THE THREADED TIP AT THE END OF THE HOLDING SLEEVE BROKE OFF WHILE THE SURGEON WAS THREADING ON A SCREW. THE TIPS OF THE CORONAL BENDERS BROKE OFF AS THE SURGEON WAS BENDING A ROD. THE BROKEN PIECES DID NOT FALL INTO THE PATIENT. THE SURGEON USED OTHER INSTRUMENTS TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THIS IS 3 OF 3 REPORTS FOR SAME EVENT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165313 CORONAL ROD BENDER-RIGHT FOR 5.5MM RODS HXW SYNTHES GMBH T935343

    Patients

    Seq Age Sex Outcome Treatment
    1