FDA Adverse Event
Malfunction
Summary report: N
MICRO RECIPROCATING SAW
MDR report key: 2853990
·
Received October 24, 2012
Report
- Report Number
- 1811755-2012-03890
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 25, 2012
- Report Date
- September 25, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CORROSION WAS DISCOVERED WITHIN INTERNAL COMPONENTS OF THE DEVICE.
Description of Event or Problem · 1
THE MICRO RECIPROCATING SAW WAS RETURNED FOR SERVICE. UPON EVAL AT THE MANUFACTURER, IT WAS FOUND TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO RECIPROCATING SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |