FDA Adverse Event
Malfunction
Summary report: N
WRIGHT DRILL BIT
MDR report key: 1764696
·
Received June 29, 2010
Report
- Report Number
- 8043862-2010-00001
- Event Type
- Malfunction
- Date Received
- June 29, 2010
- Date of Event
- April 6, 2010
- Report Date
- June 26, 2010
- Manufacturer
- AAP IMPLANTATE AG
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.
Description of Event or Problem · 1
DURING SURGERY TO REVISE PREVIOUS RIGHT TALONAVICULAR AND SUBTALAR ARTHRODESIS, TIP OF DRILL BIT BROKE OFF IN PT'S FOOT. SURGEON DETERMINED THAT THE TIP COULD BE LEFT IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WRIGHT DRILL BIT | DRILL BIT | HTW | AAP IMPLANTATE AG | IW707522 | W003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |