FDA Adverse Event
Malfunction
Summary report: N
MAESTRO DRILL
MDR report key: 2082542
·
Received April 28, 2011
Report
- Report Number
- 1811755-2011-01482
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 31, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DRILL WAS RECEIVED BY THE MANUFACTURER; HOWEVER, THE COMPLAINT COULD NOT BE REPLICATED. BASED ON THE RESULTS OF THE DEVICE EVAL, THE DRILL PERFORMED ACCORDING TO ALL SPECIFICATIONS. PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE EQUIPMENT EVAL CONDUCTED BY THE MANUFACTURER'S SALES REP, THE DRILL BEGAN SMOKING. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURIES WERE 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 |