BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3053514 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-10713
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    May 28, 2012
    Report Date
    May 28, 2012
    Manufacturer
    SYNTHES GMBH
    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

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION, VISUAL INSPECTION STATED THAT THE REAMER HEAD IS BROKEN IN THREE PIECES, WITH THE BREAK OCCURRING AT THE PROXIMAL THIRD OF THE PART. THE INTACT DISTAL TIP OF THE REAMER SHOWS SIGNIFICANT SCORING AND WEAR AT THE CUTTING TIP. THE DESIGN EVALUATION REPORT STATED A REVIEW OF THE PRODUCT DRAWING INDICATES THAT THE DESIGN IS ADEQUATE FOR THE INTENDED USE. A REVIEW OF THE RISK ANALYSIS ALSO CONFIRMS THAT IT ADEQUATELY ADDRESSES THIS EVENT. IF THE REAMER WAS MECHANICALLY OVERLOADED, DUE TO BEING WORN PRIOR TO USE OR USED IN A CANAL SMALLER THAN 8.0MM, IT COULD RESULT IN BREAKAGE. THE TECHNIQUE GUIDE PROVIDES GUIDANCE ON AVOIDING THESE CONDITIONS. THE DESIGN APPEARS TO BE ADEQUATE FOR THE INTENDED USE. BECAUSE THE CONDITIONS OF USE THAT MAY HAVE CONTRIBUTED TO FAILURE ARE NOT KNOWN, THE COMPLAINT IS DEEMED INDETERMINATE. PER THE MANUFACTURING EVALUATION THE REAMER HEAD IS BROKEN INTO THREE FRAGMENTS. ALL FRAGMENTS WERE SENT BACK FOR INVESTIGATION. THE RELEVANT DIMENSION CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE, WHILE STARTING TO USE THE REAMER HEAD, THE REAMER HEAD BROKE AT THE SIDEWALL, AND FELL APART INTO 3 PIECES. THE SURGEON VERIFIED THAT ALL PIECES WERE RETRIEVED. THE SURGEON USED A 2ND SET AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156176 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES GMBH 2162802

    Patients

    Seq Age Sex Outcome Treatment
    1