FDA Adverse Event
Injury
Summary report: N
MEDTRONIC MIDAS REX METAL CUTTING BURR
MDR report key: 12664998
·
Received October 19, 2021
Report
- Report Number
- MW5104766
- Event Type
- Injury
- Date Received
- October 19, 2021
- Date of Event
- October 15, 2021
- Report Date
- October 15, 2021
- Manufacturer
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Product Code
- HBB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
MIDAS REX METAL CUTTING BURR BROKE INTO MULTIPLE PIECES WHILE IN USE. ALL PIECES WERE RETRIEVED. SURGERY PROGRESSED AS PLANNED. NO DELAY OCCURRED. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1559983 | MEDTRONIC MIDAS REX METAL CUTTING BURR | MOTOR, DRILL, PNEUMATIC | HBB | MEDTRONIC POWERED SURGICAL SOLUTIONS | MC30 | 0222520622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |