FDA Adverse Event
Malfunction
Summary report: N
3.2 MM DRILL BIT
MDR report key: 12084596
·
Received June 29, 2021
Report
- Report Number
- 3006460162-2021-00022
- Event Type
- Malfunction
- Date Received
- June 29, 2021
- Manufacturer
- ORTHOPEDIATRICS, CORP
- Product Code
- GFG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING THE SURGERY THE DRILL BROKE, THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT OF THE DRILL FROM THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 986441 | 3.2 MM DRILL BIT | DRILL BIT | GFG | ORTHOPEDIATRICS, CORP | 01-1500-024 | 91300674-J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |