FDA Adverse Event
Malfunction
Summary report: N
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
MDR report key: 15592634
·
Received October 12, 2022
Report
- Report Number
- 15592634
- Event Type
- Malfunction
- Date Received
- October 12, 2022
- Date of Event
- May 24, 2022
- Report Date
- September 7, 2022
- Manufacturer
- BRASSELER U.S.A. MEDICAL, LLC
- Product Code
- HBE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
TIP OF DRILL BIT BROKE OFF IN INCISION DURING CLOSING. MD WAS PRESENT AND AWARE, BUT UNABLE TO RETRIEVE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1971949 | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | BRASSELER U.S.A. MEDICAL, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24090 DA | Male |