FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2130389
·
Received May 9, 2011
Report
- Report Number
- 1811755-2011-01659
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 12, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE COMPLAINT WAS DUPLICATED, THE HANDPIECE HEATED UP DUE TO CORROSION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ITEM GOT HOT AND THEN STOPPED. NO OTHER INFO WAS GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO | 0403600583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |