FDA Adverse Event
Injury
Summary report: N
BRASSELER DRILL BIT
MDR report key: 2994430
·
Received February 28, 2013
Report
- Report Number
- MW5029259
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- September 28, 2012
- Report Date
- February 28, 2013
- Manufacturer
- BRASSELER
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT WITH HISTORY OF RHEUMATOID ARTHRITIS AND DEGENERATIVE JOINT DISEASE UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. THE TIP OF A 2.5 MM DRILL BIT BROKE OFF DURING THE PROCEDURE. IT WAS FLUOROSCOPICALLY IDENTIFIED AND IMMEDIATELY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86693 | BRASSELER DRILL BIT | DRILL BIT | HWE | BRASSELER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |