HUNTER
Received Jul 13, 2017 · Event occurred Jun 15, 2017
Report 1043534-2017-00076 · MDR key 6710086
Device
Generic name
Spatula, Orthopedic
Manufacturer
Wright Medical Technology, Inc.Model number
TR300000Lot number
1594606
Product problems
- Material Rupture
- Material Rupture
Patient
62 YR
- Failure to Anastomose
- No Known Impact Or Consequence To Patient
- Failure to Anastomose
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
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
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. SOMETIME POST-OP THE TENDON ROD RUPTURED. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE TENDON ROD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
THE TENDON ROD WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMS THAT THE DEVICE HAS FRACTURED AT THE SUTURED END OF THE ROD. ALSO VISUAL EXAMINATION SHOWS THAT THE SUTURE HAD NOT BEEN PASSED THROUGH THE POLYESTER CORE WHICH INDICATES THAT THE SUTURE WAS NOT PASSED THROUGH THE POLYESTER TAPE CORE INITIALLY.