BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 6031816 · Received October 14, 2016

    Report

    Report Number
    2520274-2016-14916
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO INVESTIGATION WAS DONE ON THE DRILL BIT BECAUSE IT WAS NOT RETURNED; THE INVESTIGATION WAS COMPLETED ON THE CONCOMITANT DEVICES WHICH WERE RETURNED. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE CONCOMITANT DEVICES ASSOCIATED WITH DRILL BIT (PART NUMBER 03.010.061, LOT NUMBER UNKNOWN). THE DRILL BIT WAS NOT RETURNED. THREE CONCOMITANT PARTS WERE RETURNED; (INSERTION HANDLE - PART #: 03.008.007, LOT #: 9031696), (CONNECTING SCREW, LONG, CANNULATED - PART #: 03.010.042, LOT #: UQ61676), AND (AIMING ARM - PART #: 03.008.009, LOT #: 8887651) ALL OF THE RETURNED PARTS ARE IN GOOD CONDITION WITH MINOR WEAR AND SURFACE SCRATCHES CONSISTENT WITH USE. THE THREADS OF THE CANNULATED CONNECTING SCREW ARE INTACT WITH MINOR WEAR. THE AIMING ARM AND INSERTION HANDLE WERE ABLE TO MATE PER THE TECHNIQUE GUIDE. THE DEVICE WAS ABLE TO BE ADJUSTED FOR THE OTHER ORIENTATION OPTIONS AS WELL. THE CONNECTING SCREW FITS APPROPRIATELY IN THE INSERTION HANDLE. BECAUSE THE NAIL WAS NOT RETURNED, THE CONNECTION BETWEEN THE CONNECTING SCREW, THE INSERTION HANDLE AND THE NAIL WAS UNABLE TO BE INVESTIGATED. THIS COMPLAINT IS NOT ABLE TO BE FURTHER INVESTIGATED. BASED ON THE AVAILABLE INFORMATION THE COMPLAINT WAS UNABLE TO BE CONFIRMED. DRAWINGS WERE REVIEWED. THE MARKINGS ON THE INSERTION HANDLE WERE FOUND TO BE CORRECT. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. THE INSERTION HANDLE WAS MEASURED (FROM THE CENTER OF THE DYNAMIC HOLE TO THE CENTER OF THE THREADED ALIGNMENT PIN HOLE). THE MEASUREMENT WAS TAKEN USING GAGE PINS IN EACH OF THE HOLES, MEASURING WITH CALIPERS TO THE OUTSIDE OF EACH PIN, AND SUBTRACTING THE RADIUS OF EACH PIN FROM THE TOTAL. 9.01MM PIN WAS THE BEST FIT FOR THE THREADED ALIGNMENT PIN HOLE, 12.01MM PIN WAS THE BEST FIT FOR THE DYNAMIC HOLE MEASURED USING GAGE PINS. THE MEASUREMENT TO THE OUTSIDE OF THE PINS WAS MEASURED AT 223.97MM MEASURED USING MITUTOYO CALIPERS. IN ORDER TO DETERMINE THE MEASUREMENTS TO THE CENTER OF THE PINS, THE RADIUS OF EACH PIN WAS SUBTRACTED FROM THE CALIPER MEASUREMENT. 223.97MM - 4.505MM - 6.005MM = 213.46MM. THIS IS WITHIN THE SPECIFICATION OF 213.5MM +/- 1.2MM. A REVIEW OF RISK ASSESSMENT FOUND THE RISK SPECIFIC TO THE COMPLAINT CONDITION ADEQUATELY ADDRESSED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. DUE TO THE TIGHT TOLERANCES AND DESIGN, THE CONSTRUCT IS SUSCEPTIBLE TO LATERAL FORCES DURING THE SURGERY THAT ARE UNABLE TO BE REPLICATED DURING EVALUATION. IT IS LIKELY THAT SOFT TISSUE DISTRACTIONS FORCES ARE THE CAUSE OF THIS COMPLAINT CONDITION. DEVICE IS A DRILL BIT; PART NUMBER WAS UPDATED BASED ON INVESTIGATION FINDINGS. (B)(4). UPDATED BASED ON PART NUMBER DETERMINATION. 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 NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 10MM TITANIUM HINDFOOT ARTHRODESIS CANNULATED NAIL-EX 180MM/RIGHT-STERILE. AIMING ARM FOR TITANIUM CANNULATED HINDFOOT ARTHRODESIS NAIL-EX. CANNULATED CONNECTING SCREW WITH INTERNAL THIRD F/PERCUTANEOUS INSERTION HANDLE. INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX. THE COMPLAINT INDICATED THAT THERE WAS A FIVE MINUTES SURGICAL TIME DELAY WITH ADDITIONAL MEDICAL INTERVENTION OF THE PERFECT CIRCLE TECHNIQUE AND ADDITIONAL X-RAYS WERE TAKEN DURING THE PROCEDURE DUE TO THE MISALIGNMENT. THE SURGERY WAS LESS THAN A DESIRABLE OUTCOME AS THERE IS AN EXTRA HOLE IN THE POSTERIOR CORTEX OF THE TIBIA SHAFT. THE PATIENT EXPERIENCED PAIN AND REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE PDL IMPLANT, AND REVISE TO A COMPETITOR SPACER AND USS CONSTRUCT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR A RIGHT ANKLE FUSION ON (B)(6) 2016. THE EX HIND FOOT NAIL ASSEMBLY MISSED THE PROXIMAL TARGETING OF DYNAMIC HOLE. WHILE THE SURGEON WAS TARGETING THE PROXIMAL DYNAMIC HOLE, THE 4.2MM DRILL BIT MISSED THE NAIL HOLE. THE DRILL BIT CREATED A HOLE IN THE POSTERIOR CORTEX OF THE TIBIA. THERE WERE NO FRAGMENTS GENERATED. THE SURGEON REMOVED THE TARGETING ASSEMBLY. THE RETROGRADE ANTEGRADE FEMORAL NAIL-EX SYSTEM SET (RAFN) WAS OPENED FOR A SHORT 4.2MM DRILL BIT. THE SURGEON PROCEEDED BY USING THE 4.2MM SHORT DRILL TO TARGET THE DYNAMIC HOLE USING THE PERFECT CIRCLE TECHNIQUE TO TARGET THE LAST PROXIMAL SCREW HOLE. THERE WAS A FIVE MINUTES SURGICAL TIME DELAY WITH ADDITIONAL MEDICAL INTERVENTION OF THE PERFECT CIRCLE TECHNIQUE AND ADDITIONAL X-RAYS TAKEN DURING THE PROCEDURE. THE SURGERY WAS LESS THAN A DESIRABLE OUTCOME AS THERE IS AN EXTRA HOLE IN THE POSTERIOR CORTEX OF THE TIBIA SHAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS OUTCOME IS AS PLANNED, GOOD. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICES REPORTED: 10MM TITANIUM HINDFOOT ARTHRODESIS CANNULATED NAIL-EX 180MM/RIGHT-STERILE - PART# 04.008.016S, LOT# 7346433, QUANTITY# 1; AN AIMING ARM FOR TITANIUM CANNULATED HINDFOOT ARTHRODESIS NAIL-EX - PART# 03.008.009, LOT# - 8887651, QUANTITY# 1; A CANNULATED CONNECTING SCREW WITH INTERNAL THIRD F/PERCUTANEOUS INSERTION HANDLE - PART#03.010.042, LOT# - UQ61676, QUANTITY# 1; AND AN INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX - PART#-03.008.007, LOT# - 9031696, QUANTITY# 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681880 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION BIT, DRILL HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 03.008.007| 03.008.009| 03.010.042| 04.008.016S