BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4725002 · Received April 23, 2015

    Report

    Report Number
    1719045-2015-10239
    Event Type
    Malfunction
    Date Received
    April 23, 2015
    Date of Event
    April 3, 2015
    Report Date
    April 8, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: ONE 6.0MM/10.0MM STEPPED DRILL BIT (PART 357.403 / LOT U121548) AND ONE DRILL STOP (PART 357.405 / LOT 5079241) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT FUNCTION.¿ THE COMPLAINT CONDITION IS CONFIRMED BECAUSE WHEN THE RETURNED DEVICES WERE TESTED TOGETHER, THE DRILL STOP COULD BE MOVED OUT OF THE DESIRED SLOT WITHOUT DEPRESSING THE RELEASE BUTTON. FROM A DESIGN PERSPECTIVE, THIS COMPLAINT IS VALID, BUT HAS BEEN ADEQUATELY ADDRESSED. DURING THE INVESTIGATION, NO DISCREPANCIES WERE OBSERVED AND THE CURRENT DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE RETURNED DRILL BIT. ORCHID UNIQUE MANUFACTURED DEVICE WITH ONE NON-CONFORMANCE REPORT (NCR) GENERATED FOR ONE (1) PIECE OF THIS LOT WITH A TORN LABEL. THE PACKAGING WAS REWORKED IN-HOUSE AND THE NCR WAS CLOSED. THERE WERE NO ADDITIONAL NON-CONFORMANCES ASSOCIATED WITH THIS LOT, AND THE PARTS WERE RELEASED ON JULY 19, 2010. FURTHER EVALUATION SHOWS THAT THESE DEVICES ARE INTENDED FOR USE IN DENSE BONE TO PREPARE A PATH FOR THE FULL LENGTH OF THE HEAD ELEMENT DURING TROCHANTERIC FIXATION NAIL (TFN) PROCEDURES. PROPER USE AND MAINTENANCE IS ADDRESSES IN TECHNIQUE GUIDE. THE INSTRUCTIONS FOR CHECKING WEAR ¿ DRILL STOP CHART SPECIFICALLY RECOMMENDS THAT THE DRILL STOP/FIXATION SLEEVE SHOULD BE CHECKED BEFORE USE AND THAT IT SHOULD BE REPLACED IF IT DOES NOT PASS THE DESCRIBED WEAR TEST. THE RETURNED DRILL BIT WAS RECEIVED INTACT AND WITH WEAR CONSISTENT WITH SIGNIFICANT USE. THERE ARE SURFACE SCRATCHES AND THE CUTTING POTION SHOWS WORN EDGES. THE RETURNED DRILL STOP WAS RECEIVED INTACT AND ALSO WITH GENERAL WEAR. THERE IS SIGNIFICANT WEAR AND ROLLED EDGES ON THE ENDS OF THE DEVICE. THE BALANCE OF EACH DEVICE IS IN GOOD CONDITION AND THE ETCHINGS ARE LEGIBLE. THE RETURNED DEVICES WERE TESTED TOGETHER AND IT WAS FOUND THAT WHEN LINEAR FORCE WAS APPLIED TO THE DRILL STOP IT COULD BE MOVED OUT OF THE DESIRED SLOT. THUS, COMPLAINT CONDITION IS CONFIRMED AND COULD BE REPLICATED. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING REVISION AT THE TIME OF MANUFACTURE WAS PERFORMED. THE DESIGN HISTORY WAS FOUND TO IMPACT THE COMPLAINT CONDITION BECAUSE THESE DEVICES WERE MANUFACTURED PRIOR TO CHANGES. THESE CHANGES IMPROVED THE OVERALL ENGAGEMENT OF THE DRILL STOP PLUNGER MECHANISM WITH THE GROOVES OF THE STEPPED DRILL BIT. DURING THE INVESTIGATION, NO DISCREPANCIES WERE OBSERVED AND THE CURRENT DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THEREFORE, FROM A DESIGN PERSPECTIVE, THIS COMPLAINT IS VALID BUT HAS BEEN ADEQUATELY ADDRESSED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE DRILL STOP DID NOT STOP AT THE SET MEASUREMENT. THE DRILL BIT PROCEEDED PAST THE SET MEASUREMENT, BUT DID NOT HARM THE PATIENT. THERE WAS NO DELAY TO SURGERY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 2 COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270161 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM REAMER HTO SYNTHES MONUMENT U121548

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR