FDA Adverse Event
Malfunction
Summary report: N
5.5MM RESECTOR CUTTER, FORMULA (5BX)
MDR report key: 2133229
·
Received May 10, 2011
Report
- Report Number
- 2648666-2011-00131
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 18, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCT WAS IN USE WHEN THE END BROKE OFF INSIDE THE KNEE CAVITY. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE KNEE CAVITY. FURTHER, A REPLACEMENT PRODUCT WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.5MM RESECTOR CUTTER, FORMULA (5BX) | CUTTER | HRX | STRYKER ENDOSCOPY PUERTO RICO | 1017CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |