SWANSON HUNTER ROD SIZER SET
Received Jul 5, 2016 · Event occurred Apr 29, 2016
Report 1043534-2016-00064 · MDR key 5771222
Device
Generic name
Small Joints Instrument
Manufacturer
Wright Medical Technology, Inc.Catalog number
2437-0001
Lot number
1574329
Product problems
- Device Disinfection Or Sterilization Issue
- Packaging Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT COMPLETE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, NON STERILE SPACER IS PACKAGED IN SIMILAR FASHION AS THE STERILE IMPLANT. THE WARNING THAT THE SPACERS ARE NOT STERILE IS IN VERY SMALL PRINT ON THE SIDE OF THE BOX AND CAN BE EASILY MISSED. BOTH BOXES ARE RED AND THE SAME SHAPE AND SIZE. REPORTED THROUGH MEDWATCH.
Additional Manufacturer Narrative
THIS INCIDENT IS CONSIDERED CLOSED. IF AT ANY TIME NEW OR UPDATED INFORMATION BECOMES AVAILABLE, THE INCIDENT WILL BE RE-OPENED AND INVESTIGATED.