FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 3233902
·
Received July 18, 2013
Report
- Report Number
- 0001811755-2013-01687
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 28, 2013
- Report Date
- July 1, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OF UNINTENTIONAL ACTIVATION WAS NOT DUPLICATED. THE CUSTOMER INDICATED THAT THEY DISCOVERED AFTER SENDING THE HANDPIECE IN FOR REPAIR THAT THE ISSUE WAS ACTUALLY WITH ONE OF THEIR CABLES.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE MICRO SAGITTAL SAW RAN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT OR USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333273 | MICRO SAGITTAL SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |