FDA Adverse Event
Malfunction
Summary report: N
HUNTER
MDR report key: 7048777
·
Received November 21, 2017
Report
- Report Number
- 1043534-2017-00112
- Event Type
- Malfunction
- Date Received
- November 21, 2017
- Date of Event
- October 26, 2017
- Report Date
- October 26, 2017
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HXR
- PMA / PMN Number
- K853436
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830368 | HUNTER | SPATULA, ORTHOPEDIC | HXR | WRIGHT MEDICAL TECHNOLOGY, INC. | TR500000 | 1593246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |