BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL 16.5/3.2 CANN

    MDR report key: 3083413 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11151
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    May 31, 2012
    Report Date
    May 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION. THE CONCERNED DIMENSIONS COULD NOT BE VERIFIED AS THE SINGLE PARTS IN THESE AREAS WERE BROKEN OR WORN. EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH, AND STRUCTURAL STABILITY. THE MICROSCOPIC VIEW OF THE BROKEN WELDED LASER SEAM SHOWED THAT THE WELDING JOINT MET FULLY TO THE SPECIFICATION AFTER MANUFACTURING. IT WAS CONCLUDED THAT THE SHAFT OF THE HANDLE WAS SEPARATED FROM THE AWL-BLADE. BOTH COMPONENTS WERE INTACT WITH NO ELEMENTS OF BREAK OUT VISIBLE. THE T-HANDLE WAS BADLY BENT AND SHOWED MARKS OF MISUSE INDICATING THAT A HAMMER WAS USED ON THE INSTRUMENT TO PROPEL IT FORWARD. THE BREAKAGE WAS DUE TO MISHANDLING WHICH RESULTED IN MECHANICAL OVERLOADING. NO PRODUCT OR MATERIAL RELATED CONDITION WAS FOUND. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SSFN FEMUR AWL WAS BROKEN INSIDE THE PATIENTS TROCHANTER. INITIALLY, THE SURGEON ATTEMPTED TO CREATE A WEDGE AT THE GREATER TROCHANTER USING OSTEOTOMY BECAUSE PATIENTS BONE WAS VERY HARD. HE THEN USED THE MALLET TO KNOCK ON THE AWL, WHICH CAUSED THE AWL TO BREAK INTO TWO PARTS. THE HANDLE WAS OUTSIDE THE BODY AND THE CUTTING AWL WAS EMBEDDED INSIDE THE PATIENTS TROCHANTER. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THIS IS REPORT 2 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183636 AWL 16.5/3.2 CANN FZX SYNTHES GMBH 2666723

    Patients

    Seq Age Sex Outcome Treatment
    1