BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX CO

    MDR report key: 3003374 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10212
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE HISTORY RECORD (DHR) WAS EXAMINED TO DETERMINE WHETHER THERE WERE ANY ISSUES WHICH COULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT. THE EXAMINATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT. THE TIP OF THE SCREWDRIVER WAS RECEIVED BROKEN OFF AT THE END THAT IS USED TO SECURE THE IMPLANT. THE CERTIFICATION FROM THE SUPPLIER INDICATED THAT THE HARDNESS WAS MEASURED AS RC=54, WHICH IS IN SPEC. DUE TO THE SMALL DIAMETER SIZE OF THIS DEVICE, A SPECIMEN WITH A MUCH LARGER SURFACE AREA WAS USED TO DETERMINE THE HARDNESS AT THE SUPPLIER'S LOCATION. IN ORDER TO PERFORM A HARDNESS TEST ON A SMALL DIAMETER DEVICE IN A POST MANUFACTURING ENVIRONMENT, A VICKERS HARDNESS TEST WAS USED TO MEASURE THE HARDNESS. THE VICKERS HARDNESS MEASUREMENT WAS 629.8 AND IS EQUAL TO RC - 56.8 APPROX. FURTHERMORE, A DESIGN CHANGE WAS COMPLETED IN MARCH 2010 TO CHANGE THE MATERIAL FROM 440A TO 465 STAINLESS STEEL DUE TO ITS OPTIMUM STRENGTH AND TOUGHNESS CHARACTERISTICS, THEREBY IMPROVING PRODUCT PERFORMANCE. THIS CHANGE IN MATERIAL WAS DONE AFTER THE DEVICE WAS DISTRIBUTED AND NO FURTHER ACTION IS INDICATED. THE COMPLAINT IS DETERMINED TO BE VALID DUE TO THE OVER SPEC HARDNESS READING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A CRUCIFORM SCREWDRIVER BROKE OFF IN A 3.0MM LOCKING SCREW FROM THE TITANIUM STERNAL FIXATION SYSTEM DURING A STERNAL REVISION SURGERY. THE SURGEON USED A PAIR OF MOSQUITOS AND RETRIEVED THE BROKEN PIECE OF THE DRIVER OUT OF THE SCREW HEAD AND IT WAS DISCARDED IN THE SHARPS BIN. THE SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE SURGERY AND NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86705 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX CO HXX SYNTHES (USA) BRANDYWINE 6118696

    Patients

    Seq Age Sex Outcome Treatment
    1