FDA Adverse Event
Malfunction
Summary report: N
TRIM-IT
MDR report key: 855200
·
Received May 7, 2007
Report
- Report Number
- 855200
- Event Type
- Malfunction
- Date Received
- May 7, 2007
- Date of Event
- May 2, 2007
- Report Date
- May 7, 2007
- Manufacturer
- ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
AS THE SURGEON WAS POSITIONING THE PIN, THE TIP OF THE PIN FELL OFF. THE TIP WAS RECOVERED AND NO FOREIGN BODY WAS RETAINED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIM-IT | DRILL PIN, ORTHOPEDIC | HTW | ARTHREX ARTHROSCOPY INSTRUMENTS, INC. | * | 91141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |