FDA Adverse Event
Injury
Summary report: N
4MM BAYONETTED STRAIGHT KARRISON
MDR report key: 1221844
·
Received October 30, 2008
Report
- Report Number
- 2184052-2008-00027
- Event Type
- Injury
- Date Received
- October 30, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 29, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN SET OUT FOR TESTING, TO DETERMINE WHAT THE FOREIGN MATERIAL IS.
Description of Event or Problem · 1
THE SALES REPRESENTATIVE WAS INSPECTING AN INSTRUMENT SET BEFORE SHOWING IT TO A SURGEON. A PIECE OF WHITE FOREIGN MATERIAL WAS NOTICED ON ONE INSTRUMENT. THE SALES REPRESENTATIVE WAS PUTTING THIS INSTRUMENT BACK IN THE SET WHEN HE CUT HIS FINGER ON THE INSTRUMENT. THE INSTRUMENT IS A CUTTING INSTRUMENT FOR DISC PREPARATION. THE PART OF THE INSTRUMENT THAT CAUSED THE CUT WAS THE INTENDED CUTTING PART OF THE INSTRUMENT. THE SALES REPRESENTATIVE HAD BLOOD TESTS DONE AFTER CUTTING HIS FINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4MM BAYONETTED STRAIGHT KARRISON | 4MM BAYONETTED STRAIGHT KARRISON | GEI | ZIMMER SPINE, INC. | EX3006-02 | 9350704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |