FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL BLADE
MDR report key: 2102015
·
Received April 13, 2011
Report
- Report Number
- 9616696-2011-00054
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE FIVE DEVICES SUBJECT TO THIS INVESTIGATION WERE RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING MATERIAL OF THE FIVE BLADES WERE BRITTLE. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". AN ALTERNATIVE PACKAGING MATERIAL HAS SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A SURGICAL CASE, THE PACKAGING OF FIVE BLADES WOULD NOT OPEN. IT WAS ALSO REPORTED THAT THE BLADES WERE NOT USED ON A PATIENT AND THERE WERE NO PROCEDURAL DELAYS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL BLADE | GFA | STRYKER IRELAND LTD. | 08270017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |