BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING

    MDR report key: 2973876 · Received February 22, 2013

    Report

    Report Number
    3003787298-2013-10014
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 13, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THREE OF THE FOUR CRUCIFORM BLADES WERE BROKEN OFF NEAR THE BASE OF THE BLADE WHERE IT STARTS TO TRANSITION TO THE SHAFT. THE REMAINING BLADE WAS SLIGHTLY BENT AT THE TIP IN THE DIRECTION OF TIGHTENING A SCREW. (B)(4) WAS IMPLEMENTED IN MARCH 2011 AND CHANGED THE MATERIAL FROM 440 TO 465 PH STAINLESS STEEL TO IMPROVE THE DURABILITY OF THIS DEVICE. THIS PART WAS PRODUCED IN AUGUST 2009 PRIOR TO THAT CHANGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STERNAL RECONSTRUCTION, THE SURGEON WAS TIGHTENING THE SCREWS, AND THE HEADS OF THE DRIVERS BROKE OFF DURING THE PROCEDURE. THIS HAPPENED TO TWO DIFFERENT INSTRUMENTS DURING THE SAME CASE. THE SURGEON USED TWO ADDITIONAL SCREWDRIVERS IN THE SET TO COMPLETE THE PROCEDURE. NOTHING BROKE INTO THE WOUND, NO FRAGMENTS TO RETRIEVE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78576 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING HXX SYNTHES JENNERSVILLE 6120617

    Patients

    Seq Age Sex Outcome Treatment
    1