BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3200884 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01744
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 9, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURED THE 6.0MM/10.0MM STEP DRILL BIT CANNULATED/LARGE QC/435MM, P/N 357.403, AND LOT NUMBER U133390 ON SYNTHES PURCHASE ORDER (B)(4). THE MATERIAL AND HEAT TREAT VALUES OF THE DRILL BIT WERE CONFIRMED TO BE CORRECT. THE WIDTHS AND DIAMETERS OF THE STEPPED REGIONS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. THE PART CONFORMED TO ALL INSPECTION REQUIREMENTS AT INCOMING FINAL INSPECTION. 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 INVALID FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DATES OF MANUFACTURE: 3/23/2011 AND 4/04/2011. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT U133390 REVEALED THE 6.0MM/10.0MM STEPPED DRILL BIT, CANNULATED LARGE QC 435MM WAS MANUFACTURED BY UNIQUE INSTRUMENTS. TWO SHIPMENTS WHERE RECEIVED, PO 1244324, DATED 3/28/11 FOR 17 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 310IN133 REVISION E ON 3/29/11. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 3/23/11. SEVENTEEN PARTS WERE RELEASED TO THE WAREHOUSE ON 3/31/11. PO 1244324, DATED 4/4/11 FOR 36 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 310IN133 REVISION E ON 4/5/11. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 3/23/11. 36 PARTS WERE RELEASED TO THE WAREHOUSE ON 4/4/11.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301752 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM HTO SYNTHES MONUMENT U133390

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR