FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2033742
·
Received March 23, 2011
Report
- Report Number
- 1811755-2011-00926
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DURING THE QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED DURING TESTING. THERE WAS CORROSION DAMAGE TO THE ROTOR AND THERE WAS HEAT DAMAGE TO THE PRESS PLUG AND THE MOTOR. THE MID SPEED MOTOR WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE EVENT. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
A STRYKER MICRO SAGITTAL SAW WAS SENT IN FOR REPAIR DUE TO SMOKING DURING TESTING. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | BONE CUTTING INSTRUMENT AND ACCESSORIES | HBE | STRYKER INSTRUMENTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |