FDA Adverse Event
Malfunction
Summary report: N
MAESTRO DRILL
MDR report key: 1942308
·
Received December 22, 2010
Report
- Report Number
- 1811755-2010-02109
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 10, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 DAMAGED. IT IS UNK HOW THE HOSE DAMAGE OCCURRED, BUT MAY BE THE RESULT OF MISHANDLING. THE HOSE ASSEMBLY WAS REPLACED, AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DRILL WAS RETURNED TO THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING PRIOR TO THE START OF A SURGICAL PROCEDURE, A HOLE WAS DISCOVERED IN THE HOSE PORTION OF THE PNEUMATIC DRILL. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER 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 |