BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 2840813 · Received November 20, 2012

    Report

    Report Number
    8030965-2012-01282
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS.

    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. MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE REAMER HEAD IS BROKEN INTO 4 PIECES. THREE SMALL FRAGMENTS OF THE CUTTING TIP ARE BROKEN AWAY FROM THE LARGER HEAD FRAGMENT. THE CUTTING EDGES OF THE REAMER SHOW SCRATCHES AND WEAR AND ARE BLUNT. DUE TO THE BREAKAGE THE COMPLIANT RELEVANT DIMENSIONS CANNOT BE CHECKED TO POST-MANUFACTURING DIMENSIONS ANYMORE. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO MEET THE SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE REAMER HEAD IS BROKEN INTO 4 PIECES. THREE SMALL FRAGMENTS OF THE CUTTING TIP ARE BROKEN AWAY FROM THE LARGER HEAD FRAGMENT. THE CUTTING EDGES OF THE REAMER SHOW SCRATCHES AND WEAR AND ARE BLUNT. DUE TO THE BREAKAGE THE COMPLIANT RELEVANT DIMENSIONS CANNOT BE CHECKED TO POST-MANUFACTURING DIMENSIONS ANYMORE. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO MEET THE SPECIFICATIONS. THE DHR REVIEW SHOWS THAT THE CORRECT MATERIAL AND HARDENING PROCEDURES WERE USED. THE BROKEN SURFACES ARE HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. PRODUCT DEVELOPMENT EVALUATION WAS ALSO CONDUCTED AND THE REPORT INDICATES THERE IS SLIGHT DISCOLORATION OR SCRATCHING ON THE INSIDE SURFACE OF THE FRAGMENTS. THE CAUSE OF THE COMPLAINT IS UNCERTAIN, HOWEVER, ACCORDING TO THE EVALUATION OF SALES AND COMPLAINTS FOR THE SYNREAM SYSTEM, ALL RISKS ARE COVERED BY THE DESIGN AND CLINICAL RISK MANAGEMENT AND RESIDUAL RISKS ARE ADDITIONALLY DISCUSSED IN THE RISK MANAGEMENT SUMMARY. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE NOTED.

    Description of Event or Problem · 1

    DURING A TIBIAL ROD AND SCREW INSERTION FOR PATIENT WITH A DISTAL FEMUR FRACTURE, WHEN THE SURGEON WAS REAMING THE TIBIA TOWARDS THE PROXIMAL END, THE STARTER REAMER BROKE INTO 4 PIECES. ALL FRAGMENTS WERE RETRIEVED AS CONFIRMED BY X-RAY. THE PROCEDURE WAS EXTENDED 20 MINUTES DUE TO RETRIEVAL OF THE BROKEN DEVICE. AFTER FRAGMENT REMOVAL, THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    PATIENT WAS BEING TREATED FOR A TIBIA FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES GMBH 18805/5784706

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention