FDA Adverse Event
Malfunction
Summary report: N
MAESTRO DRILL
MDR report key: 1911481
·
Received November 17, 2010
Report
- Report Number
- 1811755-2010-01741
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 29, 2010
- Report Date
- October 29, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR AND AN INVESTIGATION IS ANTICIPATED. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED PRIOR TO THE START OF A SURGICAL PROCEDURE, THE PNEUMATIC DRILL LEAKED OIL. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAESTRO DRILL | MOTOR, DRILL, PNEUMATIC | HBB | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |