BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE FOR 4.5MM VA-LCP CURVED CONDYLAR AIMING INSTR

    MDR report key: 3080871 · Received April 26, 2013

    Report

    Report Number
    3003787298-2013-10098
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 INFORMATION: MANUFACTURING EVALUATION DETAILS, FURTHER VISUAL INSPECTION OF THE RETURNED PART NOTED, THE CASE WAS RETURNED WITH THE LID AND ALL TRAYS INCLUDED. THERE IS SLIGHT BUBBLING NOTED ON THE BORDEAUX COLORED SILK SCREEN ON THE TOP OF THE LID. THE BACK SIDE OF THE LID HAS ONE LARGE BUBBLE WHERE THE LID FOLDS TO THE SIDE. THE TOP TRAY HAS TWO BUBBLES LOCATED AT THE EDGE OF THE LONG SIDE. THE BLACK SILK SCREEN ON THE TRAYS ARE NOT AFFECTED. THE BORDEAUX SILK SCREEN ON THE BASE SHOWS NO ANOMALIES. THE DATE OF EVENT FOR THE REPORTED ISSUE IS UNKNOWN. 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 EVALUATION SHOWED THAT ONE ASSEMBLY OF P/N (60.231.016) WAS RETURNED FOR EVALUATION. THE UNIT APPEARS TO BE IN SLIGHTLY USED CONDITION WITH COLOR ADHERED TO THE SURFACE OF THE NYLON COATING FROM THE WRAPPING USED DURING THE CLEANING PROCESS. SCRATCHES ARE ALSO EVIDENT ON SEVERAL SURFACES OF THE LID P/N (60.231.007) AND THE CASE BASE P/N (60.231.008). THE NYLON COATING HAS DELAMINATED OR BUBBLED FROM THE BASE MATERIAL IS SEVERAL LOCATIONS. INVESTIGATION HAS DETERMINED THAT THE RECEIVED UNIT WAS NOT MANUFACTURED AT (B)(4) WHICH IS INDICATED BY 3 FACTORS. FIRST IS THE ORIENTATION OF RIVETS ON THE TRAY ASSEMBLIES, P/NS (60.231.005) AND (60.231.006). (B)(4) RIVETS SHOW THE ROLL ON THE TOP SURFACE, THE UNIT AS RECEIVED SHOWS ROLL ON THE BOTTOM SURFACE. SECOND INDICATION IS THE SILICONE BRACKET MATERIAL USED ON THE 60.231.005 AND 60.231.006 TRAYS. THE SILICONE BRACKET MATERIAL USED BY (B)(4) HAS A MATTE FINISH AND IS LIGHT GRAY, WHILE THE SILICONE BRACKET MATERIAL ON THE RECEIVED UNIT HAS A SHINY FINISH AND IS DARK GRAY. THIRD INDICATION IS THE SILICONE MATERIAL USED ON THE HANDLE SLEEVES (690.001.116). THE SILICONE MATERIAL USED BY (B)(4) HAS A MATTE FINISH AND IS LIGHT GRAY, WHILE THE SILICONE MATERIAL ON THE RECEIVED UNIT HAS A SHINY FINISH AND IS DARK GRAY. (B)(4) MANUFACTURING HAS EVALUATED THE UNIT PER THE COMPLAINT DESCRIPTION AND HAS CONFIRMED THE NYLON COATING OF THE UNIT HAS BEEN COMPROMISED IN SEVERAL LOCATIONS AS REPORTED FROM THE FIELD. THE COMPLAINT IS DEEMED VALID DUE TO CONFIRMATION OF THE COMPLAINED CONDITION AS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT.

    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: THE CASE WAS RECEIVED WITH THE LID AND ALL TRAYS INCLUDED. THERE IS SLIGHT BUBBLING NOTED ON THE BORDEAUX COLORED SILK SCREEN ON THE TOP OF THE LID. THE BACK SIDE OF THE LID HAS ONE LARGE BUBBLE WHERE THE LID FOLDS TO THE SIDE. THE TOP TRAY HAS TWO BUBBLES LOCATED AT THE EDGE OF THE LONG SIDE. THE BLACK SILK SCREEN ON THE TRAYS ARE NOT AFFECTED. THE BORDEAUX SILK SCREEN ON THE BASE SHOWS NO ANOMALIES. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT BECAUSE THE ENVIRONMENT THIS CASE HAS BEEN EXPOSED TO IS UNKNOWN. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS NOTICED THE GRAPHICS ON THE GRAPHIC CASE FOR 4.5 MM VA-LCP THE NYLON COATING IS BUBBLING UP. THE CASE IS APPROXIMATELY ONE MONTH OLD AND PART OF A MARKET PREFERENCE STUDY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182470 GRAPHIC CASE FOR 4.5MM VA-LCP CURVED CONDYLAR AIMING INSTR FSM SYNTHES (USA) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1