FDA Adverse Event
Malfunction
Summary report: N
MAESTRO DRILL
MDR report key: 2243678
·
Received July 28, 2011
Report
- Report Number
- 1811755-2011-02700
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 6, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DRILL WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. THE DEVICE EVAL REVEALED THAT THE DRILL PERFORMED ACCORDING TO ALL SPECS, HOWEVER THE PNEUMATIC EXHAUST HOSE WAS LEAKING OIL DUE TO HOSE DAMAGE. THE HOSE ASSEMBLY WAS REPLACED AND THE DRILL WAS RETURNED TO THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING, THE HOSE PORTION OF THE PNEUMATIC DRILL LEAKED AN UNREPORTED SUBSTANCE. THERE WAS NO PT INVOLVEMENT ASSOCIATED WITH THIS EVENT. NO USER INJURIES WERE REPORTED. ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAESTRO DRILL | HBB | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |