FDA Adverse Event
Malfunction
Summary report: N
REPAIR MAESTRO DRILL
MDR report key: 1911482
·
Received November 17, 2010
Report
- Report Number
- 1811755-2010-01744
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DRILL WAS RETURNED TO THE MANUFACTURER FOR AN UNRELATED ISSUE AND UPON EVALUATION, THE HOSE ASSEMBLY WAS FOUND TO BE DAMAGED AND LEAKING OIL. 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 A DEVICE EVALUATION CONDUCTED AT THE MANUFACTURER, OIL LEAKED FROM THE HOSE PORTION OF THE PNEUMATIC DRILL. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PATIENT 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 | REPAIR MAESTRO DRILL | MOTOR, DRILL, PNEUMATIC | HBB | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |