FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2090665
·
Received April 19, 2011
Report
- Report Number
- 1811755-2011-01302
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
QUALITY INVESTIGATION REVEALED CORROSION DAMAGE THROUGHOUT THE INTERNAL PARTS OF THE DEVICE. THE PRESS PLUG, MOTOR, ROTOR, BEARINGS AND OTHER COMPONENT PARTS WERE DAMAGED. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
A STRYKER SAGITTAL SAW WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |