BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM FRAG LCP INSTR/IMPL SET GRAPHIC CASE W/O SCR RACK

    MDR report key: 3032216 · Received April 3, 2013

    Report

    Report Number
    3003787298-2013-10062
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. THE MANUFACTURING EVALUATION SHOWED THAT ONE UNIT PART NUMBER (60.212.005) RECEIVED CONDITION IS USED. THE NYLON COATING OF THE GRAPHIC CASE BASE, LID AND BRACKETS ARE INTACT. THERE IS LABELING TAPE ON THE EXTERNAL SURFACE OF THE CASE BASE AND INK MARKINGS ON THE INTERIOR TRAY FROM INK MARKER OR SHARPIE. THE UNIT WAS INVESTIGATED USING TOP LEVEL REVISION E DRAWINGS. THE CASE BASE HAS DISCOLORATION ON ALL EXTERNAL AND INTERNAL SURFACES DUE TO THE FOLLOWING; PLACEMENT OF IDENTIFICATION TAPE INSTALLED BY THE CUSTOMER. THERE IS ALSO DISCOLORATION OR RESIDUE FROM THE WRAPPING MATERIAL USED DURING THE STERILIZATION/CLEANING PROCESS. FURTHER DISCOLORATION OR RESIDUE IS EVIDENT ON MULTIPLE SURFACES OF THE UNIT INCLUDING THE NYLON COATED POSITIONING BRACKET FROM THE USE OF AN INK MARKER OR SHARPIE STYLE INK PEN. NO EVIDENCE OF CORROSION OR SIMILAR CONTAMINATION IS DETECTED. ALL STAINLESS STEEL COMPONENTS ARE LIKE NEW WITH NO SURFACE DEGRADATION. IT IS CONCLUDED THAT THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. 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. ADDITIONAL NARRATIVE: (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAPHIC CASE IS CORRODING. CORROSION DEPOSITS RESIDUE IS ON THE INSTRUMENTS AND IMPLANTS IN THE CASE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137037 SM FRAG LCP INSTR/IMPL SET GRAPHIC CASE W/O SCR RACK FSM SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1