FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT SQC 2.0MM 100/21.5MM
MDR report key: 20032735
·
Received August 21, 2024
Report
- Report Number
- MW5158655
- Event Type
- Malfunction
- Date Received
- August 21, 2024
- Report Date
- August 19, 2024
- Manufacturer
- GSOURCE LLC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DRILL BIT BROKE DURING ORTHOPEDIC SURGERY. THE DRILL BIT PIECE WAS ABLE TO BE RETRIEVED. THIS IS THE THIRD EVENT REPORTED FOR OUR FACILITY SINCE (B)(6) 2024 INVOLVING THIS SAME DRILL BIT BREAKING DURING ORTHOPEDIC SURGERY. APIARY MEDICAL INC. REFERENCE REPORTS MW5158653, MW5158654.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1381105 | DRILL BIT SQC 2.0MM 100/21.5MM | BIT, DRILL | HTW | GSOURCE LLC. | GS 86.8220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |