Product Experience Report
Section 1 - To be completed by Sales Representative, Sales Coordinator, or Document Control/Regulatory
Complaint Filled Out by
*
Surgeon Name/Rep Name/Employee Name
*
Hospital/Site
*
Part Information
*
Rows
P/N
Lot #
Qty
Part 1
Part 2
Part 3
Complaint Relates to
*
Sterility
Design
Packaging
Foreign Material
Product Malfunction / Broken
Labeling
Revision of TJO Implants
Other (specify below)
Other
Surgical Impact
*
Cancelled
Intervention
Procedural Delay
Patient / User Death
Revision of TJO Implants
Patient / User Injury
None
Detailed Description of Issue
Date of Occurrence
*
-
Month
-
Day
Year
Date
Description of Issue
*
At what point was the issue identified (during inspection of parts, during surgery, during cleaning, etc.)?
*
Was the part used in an unusual way? (If "yes", describe how it was used.)
*
Yes
No
Describe how part was used:
*
Were all the pieces recovered?
*
Yes
No
Did a new part need to be pulled from another set to complete surgery?
*
Yes
No
Detailed Description of Surgical Approach, where applicable:
*
include type and style of Surgical Approach, eg. small incision anterior
Customer Requests Follow-up
*
Yes
No
File Upload (Picture of Part)
*
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of
Submit
TOTAL JOINT ORTHOPEDICS
MISSION-DRIVEN™
1567 East Stratford Ave.
Salt Lake City, Utah 84106
o. 888.890.0102 f. 801.486.6117 sales@tjoinc.com
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