FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2101928
·
Received May 18, 2011
Report
- Report Number
- 1811755-2011-01806
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DURING FAILURE ANALYSIS VISUAL EXAMINATION REVEALED WORN/DAMAGED INTERNAL COMPONENTS. CORROSION DAMAGE WITHIN THE MOTOR, ROTOR, PRESS PLUG AND BEARINGS WAS NOTED. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED, CLEANED, LUBED, ADJUSTED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE STRYKER MICRO SAGITTAL SAW WAS SENT FOR EVAL DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |