SWANSON HUNTER ROD SIZER SET
Received Apr 24, 2018 · Event occurred Mar 15, 2018
Report 1043534-2018-00030 · MDR key 7453749
Device
Generic name
Prosthesis, Tendon, Passive
Manufacturer
Wright Medical Technology, Inc.Model number
SEE H10Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE PART NUMBER OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 24370003, 24370004, 24370005 AND # 24370006. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem
ALLEGEDLY, THE SURGEON INSERTED A TENDON SPACER SIZER TRIAL IN THE PATIENT BY MISTAKE. (THE SIZER HAD BEEN STERILIZED.) COMMENTS FROM SURGEON: THE SIZER WILL BE REMOVED IN A FEW MONTHS SO TILL THEN, THE SURGEON WOULD LIKE TO LEAVE IT IN THE PATIENT UNLESS IT IS NECESSARY TO REMOVE IT IMMEDIATELY. NO PATIENT COMPLICATIONS WERE REPORTED.
Description of Event or Problem
PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE TRIAL.