1. • Modular Graphic Case systems are designed to hold components and instruments required for surgical procedures.
• Prior to Q3 2015 the cases were manufactured and assembled at Synthes’ Jennersville facility in Pennsylvania. Following decommissioning of
this facility the process and equipment were transferred to Flextronics’ facility in Juarez, Mexico.
• Validation attempts were made in January 2016 to qualify the conveyor oven used to cure the ink to the case’s surface. The qualifications were
unsuccessful due to atypical adhesion results and loss of ink. A Technical Assessment was initiated to understand the results.
• Three Engineering studies were completed by Flextronics in
February 2016 to confirm atypical adhesion issue was not
equipment specific.
• A site audit was performed at Diamond State Graphics to
evaluate process controls and the silk screen printing process.
• Engineering studies at Diamond State Graphics suggested that
degassing of the ink was required prior to shipment of parts.
• Additionally an evaluation found that the anodizing layer
prepared at IndustraPlate was also critical for adhesion
success.
• Design of Experiments (DOE) evaluated CPPs for the
Anodization and Silk Screen Printing processes.
• Anodization dwell time
• Catalyst/ink ratio
• Curing time of ink after application
• Oven curing temperature and time
IndustraPlate – DE
• Anodize
Diamond State
Graphics – DE
• Silk Screen Print
Flex – Juarez
• Machining
Flex – Juarez
• Assembly
• Final Inspection
Process Focus
• Surface studies
• Sample size
• CPPs for anodize and silk screen
• Multiple manufacturing / processing sites for machining, anodizing, silk screen printing, curing, assembly and inspection. Additional part
handling and shipping increased likelihood of defects.
o Aluminum sheets received at Flextronics’ facility for fabrication of graphic cases and trays
o Assembled units are shipped to IndustraPlate (Wilmington, DE) for anodizing and sealing.
o Anodized parts are shipped to Diamond State Graphics (Wilmington, DE) for silk screen printing.
• Limited knowledge on the impact of anodized surfaces has on ink adhesion
• Lack of process validations and process controls
Anodizing and Silk Screen
Process Parameters
Qualification
Experiments
Surface Study
Investigations
DOE Studies for
Anodizing and Silk
Screen CPPs
Process Validations
StdOrder RunOrder CenterPt Blocks
Anodize
Process
Parameters
Printing
Process
Parameters
Type of
specimen
Adhesion
Test Results
Oxide
Thickness
Replicates
Adhesion Test
(Pass/Fail)
Average
Oxide
Thickness
2 10 1 1 High Low Coupon 2/15 Passed 20.75 2 Fail 24.13
10 34 1 1 High Low Coupon 2/15 Passed 22 2 Pass 24.13
18 33 1 1 High Low Coupon 2/15 Passed 24.25 2 Fail 24.13
26 24 1 1 High Low Coupon 2/15 Passed 24.25 2 Fail 24.13
34 46 1 1 High Low Coupon 2/15 Passed 25.75 2 Pass 24.13
42 22 1 1 High Low Coupon 2/15 Passed 27.75 2 Fail 24.13
3 42 1 1 Low High Coupon Pass 6.25 3 Pass 9.13
11 8 1 1 Low High Coupon Pass 8.25 3 Pass 9.13
19 12 1 1 Low High Coupon Pass 8.9 3 Pass 9.13
27 9 1 1 Low High Coupon Pass 8.9 3 Pass 9.13
35 13 1 1 Low High Coupon Pass 9 3 Pass 9.13
43 6 1 1 Low High Coupon Pass 13.5 3 Pass 9.13
6 3 1 1 High Low Case Pass 20 6 Pass 20.24
14 32 1 1 High Low Case Pass 18 6 Pass 20.24
22 25 1 1 High Low Case Pass 21.75 6 Pass 20.24
30 16 1 1 High Low Case Pass 22 6 Pass 20.24
38 11 1 1 High Low Case Pass 19.5 6 Pass 20.24
46 15 1 1 High Low Case Pass 20.2 6 Pass 20.24
7 35 1 1 Low High Case Pass 8.75 7 Pass 9.16
15 40 1 1 Low High Case Pass 8.25 7 Pass 9.16
23 19 1 1 Low High Case Pass 8.25 7 Pass 9.16
31 45 1 1 Low High Case Pass 10.5 7 Pass 9.16
39 4 1 1 Low High Case Pass 10 7 Pass 9.16
47 2 1 1 Low High Case Pass 9.2 7 Pass 9.16
Failures for anodize process at Low Parameters and printing process at High parameters
Passed Specimen