FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1910586
·
Received November 12, 2010
Report
- Report Number
- 1910586
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 29, 2010
- Report Date
- November 12, 2010
- Manufacturer
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Product Code
- HBF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MIDAS B-1 DRILLING TIP BROKE OFF WHILE DRILLING HOLES INTO SKULL BONE FLAP ON MAYO. TIP FOUND. NO INJURY TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) | HBF | MEDTRONIC POWERED SURGICAL SOLUTIONS | * | 0004308430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |