FDA Adverse Event
Malfunction
Summary report: N
MAESTRO DRILL
MDR report key: 2082056
·
Received April 26, 2011
Report
- Report Number
- 1811755-2011-01419
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 30, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY THE MFR; HOWEVER THE LEAKING AIR COMPLAINT COULD NOT BE REPLICATED. THE DRILL MOTOR HOSE ASSEMBLY WAS REPLACED, AND PREVENTATIVE MAINTENANCE WAS PERFORMED. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING, THE PNEUMATIC DRILL WAS LEAKING AIR. THERE WAS NO REPORT OR ANY OIL LEAKAGE FROM THE DEVICE. 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 | HBB | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |