BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING

    MDR report key: 3031005 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-10320
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    May 15, 2012
    Report Date
    May 15, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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. MANUFACTURING EVALUATION; THE VISUAL INSPECTION REPORT STATED THAT ALL FOUR OF THE CRUCIFORM BLADES ARE BROKEN OFF NEAR THE BASE OF THE BLADE WHERE IT STARTS TO TRANSITION TO THE SHAFT. THERE ARE SOME SURFACE SCRATCHES AT THE COUPLING END THAT APPEAR TO BE FROM MATING WITH A HANDLE. THE EVALUATION OF PARTS ON PREVIOUS COMPLAINTS HAVE FOUND THAT THE HARDNESS HAS EXCEEDED THE UPPER LIMIT (SPEC 50 - 55) AND HAVE BEEN DEEMED VALID. THE PARTS EVALUATED ON COMPLAINTS 192065 AND 191975 WERE FROM LOT 9129330, WHICH WAS THE LOT PRODUCED IMMEDIATELY BEFORE THE ONE NOTED ON THIS COMPLAINT, AND WAS FOUND TO HAVE A HARDNESS OF 57.4 AND WAS THEREFORE DEEMED VALID. BASED ON THAT AND OTHER PREVIOUS COMPLAINTS THAT HAVE DEEMED VALID FOR THE SAME CONDITION, THIS COMPLAINT IS VALID. DCO 10012095 WAS IMPLEMENTED IN (B)(6) 2011 AND CHANGED THE MATERIAL FROM 440 TO 465 PH STAINLESS STEEL TO IMPROVE THE DURABILITY OF THIS DEVICE. THIS PART WAS PRODUCED IN SEPTEMBER 2009 PRIOR TO THAT CHANGE. PARTS WERE SENT TO THE MECHANICAL TEST LABS FOR HARDNESS TESTING. PARTS FAILED HARDNESS TESTING. THIS COMPLAINT IS VALID. AN INTERNAL CORRECTIVE 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)

    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.THE DEVICE HISTORY RECORD WAS REVIEWED 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(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STERNAL FIXATION PROCEDURE, THE SURGEON WAS BENDING THE TI STERNAL LOCKING PLATE (460.008) AND THE PIN BROKE. THE BROKEN PIN IS LODGED IN THE PLATE. THE SURGEON USED ANOTHER PLATE. THE SURGEON WAS INSERTING THE SCREW AND THE TIP OF THE CRUCIFORM SCREWDRIVER (313.939) SHEERED OFF. THE BROKEN FRAGMENT WAS RETRIEVED AND DISCARDED. THE SURGEON USED ANOTHER SCREWDRIVER AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. COMPLAINT #2 OF 2.

    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
    135097 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING HXX SYNTHES BRANDYWINE 6129331

    Patients

    Seq Age Sex Outcome Treatment
    1