HUNTER
Received Nov 21, 2017 · Event occurred Oct 26, 2017
Report 1043534-2017-00112 · MDR key 7048777
Device
Generic name
Spatula, Orthopedic
Manufacturer
Wright Medical Technology, Inc.Model number
TR500000Lot number
1593246
Product problems
- Break
- Migration or Expulsion of Device
- Break
- Migration or Expulsion of Device
Patient
42 YR
- No Known Impact Or Consequence To Patient
- 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 WITH A HUNTER TENDON ROD BEING IMPLANTED. THE SURGEON TOOK X-RAYS 9 DAYS POST-OP AND THE ROD WAS INTACT AND WHERE IT SHOULD BE. ALLEGEDLY, 3 MONTHS POST-OP THE SURGEON AGAIN TOOK X-RAYS IN PREPARATION FOR THE SECOND PHASE OF THE SURGERY. THE SURGEON NOTICED THE ROD HAD BROKEN WITH APPROXIMATELY 1 CM STILL ATTACHED DISTALLY AND THE OTHER PORTION OF THE ROD HAD MIGRATED 2 CM.