BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 3072645 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10718
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED WITH THE SMALL DIAMETER PORTION OF THE CONNECTION COUPLING BROKEN OFF THE SHAFT. MEASURABLE DIMENSIONS WERE WITHIN SPECIFICATION. DUE TO MISSING PORTIONS, VERIFICATION FOR PHYSICAL DIMENSIONS COULD NOT BE COMPLETED. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED, THE BREAKAGE OF THE REAMER COULD BE CAUSED BY A BENT GUIDE WIRE THAT CREATES A STRESS FRACTURE AT THE TIP, LONG TERM USE THAT CAUSES WEAR ON THE CUTTING EDGES WHICH REDUCES CUTTING EFFICIENCY, INAPPROPRIATE MATERIAL SPECIFIED, AND EXTREMELY DENSE BONE. IT WAS NOT REPORTED THAT THE GUIDE WIRE WAS BENT. THE MATERIAL GRADE USED COULD ACCELERATE WEAR ON THE CUTTING FLUTES, REDUCE THE OVERALL STRENGTH AND REDUCE OVERALL CUTTING EFFICIENCY. THE MATERIAL USED ON THIS REAMER IS TYPICAL FOR CUTTING INSTRUMENTS. THE REAMER PACKAGING INCLUDES THE INSERT, IMPORTANT INFORMATION ON THE RECOMMENDED PREPARATION OF DRILL BITS AND TAPS FOR RE-USE. THIS INSERT OUTLINES THE PROPER RE-USE AND CARE FOR DRILL BITS AND TAPS. THE INSERT SPECIFIES TO CHECK DRILL BITS AND TAPS AND DISCARD IF STAINS, RUST, RESIDUE, OR DAMAGE SUCH AS BLUNT EDGES, BENT SHAFTS, ARE PRESENT. IT APPEARS FROM EVALUATION OF THE DEVICE THAT THE DRILL BIT HAD BECOME WORN AND THE CUTTING EFFICIENCY REDUCED. THIS MOST LIKELY RESULTED IN THE INABILITY OF THE DRILL TO CUT AND ADVANCE, CAUSING AN OVER TORQUE SITUATION AND SUBSEQUENT FAILURE OF THE DRILL. PER THE PROVIDED INSERT, THE INSTRUMENT SHOULD HAVE BEEN CHECKED AFTER EACH USE AND CLEANED TO INSURE THAT THERE WERE NOT SIGNS OF DEGRADATION SUCH AS RUST OR BLUNT CUTTING EDGES. HOWEVER, IT IS NOT POSSIBLE TO KNOW IF THIS WAS EXACTLY THE CAUSE. SINCE THE MATERIAL SPECIFIED IS APPROPRIATE AND WITHIN SPECIFICATIONS AND A DEVICE INSERT WAS PROVIDED DESCRIBING THE PROPER USE AND CARE OF THE INSTRUMENT, NO DESIGN CHANGES ARE WARRANTED. THIS COMPLIANT IS CONSIDERED INVALID.

    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 RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ORIGINAL AWARENESS DATE IS 07/14/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, WHILE USING THE DRILL BIT ATTACHED WITH A JACOBS CHUCK TO A STRYKER DRILL, THE TIP OF THE DRILL BIT BROKE OFF. THE SURGEON USED ANOTHER DRILL TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES OF THE DRILL BIT WERE RETRIEVED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175013 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM HTO SYNTHES MONUMENT U135810

    Patients

    Seq Age Sex Outcome Treatment
    1