FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT SQC 2.5MM 110/32MM
MDR report key: 21638664
·
Received March 18, 2025
Doing adverse event research by hand?
The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.
Free to try · every answer cites its records
Report
- Report Number
- 2249529-2025-00002
- Event Type
- Malfunction
- Date Received
- March 18, 2025
- Report Date
- March 18, 2025
- Manufacturer
- GSOURCE, LLC
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
REFER TO COMPLAINT FILE: (B)(4).
Description of Event or Problem · 0
IT WAS A COMPLAINT ABOUT 3 DRILLS BROKE DURING SURGERY; DIFFERENT SURGERIES AND DIFFERENT SURGEONS. BROKEN DRILL BIT DID NOT REMAINED IN ANY PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3205 | DRILL BIT SQC 2.5MM 110/32MM | DRILL BIT SQC | HTW | GSOURCE, LLC | GS 86.8226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |