FDA Adverse Event
Malfunction
Summary report: N
MAESTRO DRILL
MDR report key: 1813007
·
Received August 11, 2010
Report
- Report Number
- 1811755-2010-00930
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- June 29, 2010
- Report Date
- July 21, 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 RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. A VISUAL EXAMINATION OF THE DRILL CONFIRMED THAT THE PNEUMATIC HOSE WAS TORN OR CUT. THE HOSE ASSEMBLY WAS REPLACED, AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DEVICE WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE CLEANING PROCESS, A TEAR WAS DISCOVERED IN THE HOSE PORTION OF THE PNEUMATIC DRILL. IT IS UNK HOW THE DAMAGE OCCURRED. 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 |