BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS

    MDR report key: 3208793 · Received July 8, 2013

    Report

    Report Number
    1719045-2013-01763
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION: MANUFACTURING DATE: 3/09/2001 AND 3/20/2001. ENVISION MANUFACTURING INC. (PRESENTLY SMALL BONE INNOVATIONS) MANUFACTURED THE SELF-RETAINING SCREWDRIVER, P/N 387.282, AND SYNTHES LOT NUMBERS 4241719 AND 4247154 (SUPPLIER LOT 6222). THE SUPPLIERS CERTIFICATES OF COMPLIANCE (DATED FEBRUARY 27, 2001 AND MARCH 8, 2001 FOR LOTS 4241719 AND 4247154 RESPECTIVELY) INDICATE THE PARTS WERE MANUFACTURED TO P/N 387.282, REVISION A AND MET THE REQUIRED SPECIFICATIONS. THE LOTS WERE INSPECTED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION FO (DATED MARCH 5, 2001 AND MARCH 14, 2001 RESPECTIVELY). (B)(4) WAS GENERATED FOR THE HEAT TREAT REQUIREMENT NOT DOCUMENTED ON THE CERTIFICATE OF COMPLIANCE FOR LOT 4241719, BUT WAS FOUND CONFORMING AND CLOSED MARCH 7, 2001. THERE WERE NO OTHER MRRS, NCRS, OR COMPLAINT RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. LOT 4241719 WAS RELEASED MARCH 9, 2001 AND LOT 4247154 WAS RELEASED MARCH 20, 2001. PRODUCT WENT TO MANUFACTURING TO BE EVALUATED: THE MATERIAL OF THE SCREWDRIVER WAS CONFIRMED TO BE CORRECT. THE PART CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS AT SYNTHES INCOMING INSPECTION. THE ROOT CAUSE IS UNKNOWN. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RESULTS OF THE PRODUCT DEVELOPMENT EVALUATION SHOW THE FOLLOWING: THE CERVICAL SPINE LOCKING PLATE (CSLP) SYSTEM INCLUDES TWO SELF-RETAINING SCREWDRIVERS (387.282) TO INSTALL EXPANSION HEAD SCREWS. IN ADDITION, THIS DRIVER INSTALLS THE TEMPORARY FIXATION PINS (387.595). THE CHU REVIEWED THE ASSOCIATED DRAWINGS FOR THIS INSTRUMENT. THESE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIAL, AND FINISHING PROCESS FOR A SUCCESSFUL DRIVER. THE LOT NUMBER FOR THIS INSTRUMENT IS 6222. SYNTHES RECEIVED THIS LOT IN MARCH 2001. THE HANDLE FRACTURED AT THE PINNED CONNECTION. THE DRIVER TIP DOES NOT SHOW EVIDENCE OF EXCESSIVE TORQUE. BASED ON THE LOT NUMBER INFORMATION, THE ROOT CAUSE MAY BE RELATED TO THE AGE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND FOUR (4) SCREWS AT C6-C7 ON AN UNKNOWN DATE. IT IS REPORTED PATIENT WAS FUSED AT THIS LEVEL. PATIENT DEVELOPED ADJACENT LEVEL DISC DISEASE AT C5-C6. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2013 FOR THE REMOVAL OF THE PREVIOUS PLATE AND SCREWS. SURGEON IMPLANTED NEW PLATE AND SCREWS AT C5-C6. DURING THE PROCEDURE, THE HANDLE OF THE SCREWDRIVER BROKE. NO PIECES OR FRAGMENTS FELL INTO THE PATIENT, ALL PIECES WERE RETRIEVED. IT IS REPORTED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309008 SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS FSM SYNTHES MONUMENT 6222

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR