BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL STOP

    MDR report key: 3200885 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01743
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 9, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORD FOR LOT 6394299 REVEALED THE DRILL STOP WAS MANUFACTURED BY ISIMAC MACHINE COMPANY. (B)(4), DATED (B)(4) 2010, FOR 50 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) 2010. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED (B)(4) 2010. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURED THE DRILL STOP, P/N 357.405, AND LOT NUMBER 6394299 ON SYNTHES PURCHASE ORDER (B)(4). THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING AT SYNTHES INCOMING INSPECTION. THE MATERIALS OF THE DRILL STOP HOUSING AND BUTTON WERE CONFIRMED TO BE CORRECT. FUNCTIONAL TESTING WAS PERFORMED USING GAGE GT026298 AND THE DRILL STOP PASSED THE FUNCTIONAL TEST WHEN PULLED IN BOTH DIRECTIONS. WHEN FUNCTIONAL TESTING WAS PERFORMED WITH THE DRILL BIT ALSO RETURNED ON THIS COMPLAINT, THE DRILL STOP HELD IN ONE DIRECTION, BUT SLIPPED WHEN PUSHED IN THE OPPOSITE DIRECTION. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE TROCHANTERIC FIXATION NAIL RISK ANALYSIS (P99-012, VERSION E) ADEQUATELY ASSESSES THE RISK OF THIS COMPLAINT CONDITION. SPECIFICALLY, THE 4TH HAZARD LISTED UNDER "HELICAL BLADE DRILLS AND DRILL STOP (357.403, 357.404, 357.405)" IS "DRILL DOES NOT FUNCTION WITH DRILL STOP" AND IS ASSESSED AS A LESS SEVERE RISK WITH A MODERATE SEVERITY OF HARM "3" AND AN IMPROBABLE PROBABILITY OF OCCURRENCE "2" WITH POSSIBLE HARM LISTED AS "DRILL WILL SLIDE AND WILL ALLOW THE DRILL BIT TO GO TOO DEEP AND REMOVE TOO MUCH BONE THAT WOULD BE NEEDED TO HOLD THE HELICAL BLADE". THIS COMPLAINT IS VALID AND CAPA #153 WAS ALREADY IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE STEP DRILL BIT STOP IS SLIPPING FOR THE TROCHANTERIC FIXATION NAIL DURING THE PROCEDURE. THE DEVICE WAS SET FOR A DEPTH OF 95MM, BUT DRILLED TO 100MM. THE CASE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO IMPACT TO THE PATIENT AND NO DELAY IN SURGICAL TIME. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303238 DRILL STOP FZX SYNTHES MONUMENT 6394299

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR