BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS

    MDR report key: 3020739 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10392
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    August 31, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SUPPLIER'S CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 EVENT EVALUATION REPORTS THAT THE DRILL/TAP AND SCREW GUIDE, 03.613.001, INTENDED USAGE IS FOR SOFT TISSUE PROTECTION; THE POST MATES WITH A HOLE IN THE PLATE FOR PROPER ALIGNMENT. THE TECHNIQUE GUIDE STATES, THE DTS GUIDE MAY ONLY BE USED FOR SOFT TISSUE PROTECTION. IF THE DTS GUIDE IS USED FOR TISSUE RETRACTION, THE DTS GUIDE MAY BREAK. BASED ON THE WAY THE POST AND FLANGES WERE BENT AND THE BREAKAGE NOTED ON THE DRILL/TAP (LOT 1407390), IT IS EVIDENT THAT THE RETURNED DEVICES WERE USED FOR RETRACTION AND/OR BONE REDUCTION AND THIS IS THEREFORE INVALID FROM A DESIGN AND MANUFACTURING STANDPOINT. THE RETURNED SCREWDRIVER FOR EXPANSION HEAD SCREWS (387.282, LOT 116270) WAS MANUFACTURED IN AUGUST 2000 AND IS OVER 12 YEARS OLD. THIS HAS BEEN PREVIOUSLY EVALUATED BY MANUFACTURING AND THE MATERIAL, HARDNESS AND SHAFT DIAMETER WERE VERIFIED AND CONFORMED TO SPECIFICATIONS. THE EXPANSION HEAD IS MADE FROM STANDARD MATERIALS FOR DEVICES OF THIS TYPE AND BASED ON THE AGE OF THE RETURNED INSTRUMENT AND THE LIMITED NUMBER OF PRIOR COMPLAINTS, THE DESIGN IS ADEQUATE FOR THE INTENDED USE. THE LOT NUMBER ON THE RETURNED EXTRACTION SCREWDRIVER WAS NOT REPORTED THEREFORE THE AGE OF THE DEVICE COULD NOT BE DETERMINED. IN ADDITION, THE INNER SHAFT WAS NOT RETURNED AND THEREFORE THE EVALUATION COULD NOT BE COMPLETED. IT APPEARS THAT THE INSTRUMENT WAS INSERTED AND USED OFF ANGLE WHICH POSSIBLY INCREASED THE LOADING ON ONE SIDE OF THE TIP WHICH COULD LEAD TO THE OBSERVED BREAKAGE. THE AMOUNT OF TORQUE REQUIRED TO REMOVE A SCREW IS LESS THAN THE TORQUE NEEDED TO BREAK THE DRIVER TIP. IT IS POSSIBLE THAT THE DRIVER WAS SUBJECTED TO A SIDE LOAD AND/OR ADDITIONAL FORCES THAT COULD HAVE CAUSED THE BREAKAGE. THIS FAILURE MODE IS NOT CONSISTENT WITH TYPICAL USAGE. THE DESIGN OF THE RETURNED PARTS IS ADEQUATE FOR THEIR INTENDED USES AND THIS COMPLAINT IS THEREFORE INVALID. THERE WAS NO ISSUE FOUND WITH ONE OF THE DRILL/TAP AND SCREW (DTS) GUIDES AND THE HEX SCREWDRIVER AND BOTH DEVICES FUNCTIONED AS INTENDED. THE COMPLAINT CONDITION FOR THE OTHER DTS GUIDE AND EXTRACTION SCREWDRIVER ARE DUE TO MISUSE FROM BEING USED FOR REDUCTION/RETRACTION AND FROM BEING INSERTED OFF AXIS. THE COMPLAINT CONDITION WITH THE EXPANSION HEAD AND LOCKING SCREW SCREWDRIVERS IS DUE TO WEAR AND TEAR OVER AN EXTENDED PERIOD OF TIME AND ARE NOT RELATED TO ANY DESIGN ISSUES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 THERE WERE SEVEN BROKEN INSTRUMENTS. IT IS UNKNOWN WHEN OR HOW THEY BROKE AND NO ADDITIONAL INFORMATION IS AVAILABLE. IT WAS REPORTED THAT SEVEN ITEMS WERE BROKEN, ONE HAD A BROKEN TIP. TWO OF THE ITEMS WERE DRILL GUIDES WITH BROKEN TIPS, ONE KNOB ON THE HANDLE WAS BROKEN, ONE HAS THE TIP STRIPPED OFF. THE TIP OF THE JAW IS BROKEN ON ONE OF THE ITEMS AND THE BROKEN PIECE WAS DISCARDED. THIS IS FOUR OF FOUR REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123283 SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS HXC SYNTHES MONUMENT 116270

    Patients

    Seq Age Sex Outcome Treatment
    1