FDA Adverse Event
Malfunction
Summary report: N
MCP SZ. 40 PROXIMAL WW
MDR report key: 4102668
·
Received August 28, 2014
Report
- Report Number
- 1651501-2014-00043
- Event Type
- Malfunction
- Date Received
- August 28, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 1, 2014
- Manufacturer
- ASCENSION ORTHOPEDICS
- Product Code
- NEG
- PMA / PMN Number
- P000057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED DURING A TWO JOINT PYROCARBON MCP SURGICAL CASE, THE SHAFT OF A SIZE 40 PROXIMAL MCP JOINT FRACTURED MID STERN, IN THE INTRAMEDULLARY CANAL. IT TOOK EXTRA TIME TO REMOVE THE FRACTURED IMPLANT. A SPARE DEVICE WAS AVAILABLE AND USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY TO THE PATIENT REPORTED. THE SURGERY TIME WAS INCREASED 20 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523882 | MCP SZ. 40 PROXIMAL WW | NEG | ASCENSION ORTHOPEDICS | 13-0086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |