BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM/2.5MM INSERT DRILL SLEEVE

    MDR report key: 3062934 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10944
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    July 6, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE 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. (B)(4). 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 MANUFACTURING EVALUATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. REGARDING CORROSION IT CAN BE STATED, THAT ALL MATERIALS, INCLUDING SO CALLED STAINLESS STEEL AS WELL, ARE CONDITIONALLY ONLY RUST-RESISTANT. THE CORROSION RESISTANCE IS MAINTAINED ONLY, WHEN THE MATERIAL IS STORED ON A DRY AND METALLIC CONTACT LESS CONDITION. ALL METALLIC CONTACTS ON HUMID OR WET CONDITION CREATE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS RESULT. THE INVESTIGATION RESULTS WERE INDETERMINATE.

    Description of Event or Problem · 1

    SYNTHES (B)(6) ADVISED: ON (B)(6) 2011, SYNTHES INSTALLED APPROXIMATELY 75 NEW SETS INTO THE HOSPITAL, 5 OF THESE NEW SETS WERE SMALL FRAGMENT SETS. AFTER ONLY 2 MONTHS, THE INSTRUMENT ROOM NOTICED THAT 2 OF THE 40 INSTRUMENTS IN EACH OF THE NEW SMALL FRAGMENT SETS WERE RUSTING WHERE THE PART AND LOT NUMBERS ARE ETCHED ON THE INSTRUMENTS. THIS IS 1 OF 2 REPORTS FOR THIS EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165981 3.5MM/2.5MM INSERT DRILL SLEEVE FZX SYNTHES GMBH 3286537

    Patients

    Seq Age Sex Outcome Treatment
    1