FDA Adverse Event
Malfunction
Summary report: N
3.5MM 6 FLUTE ROUND BUR - HOLLOW, FORMULA (5BX)
MDR report key: 1894282
·
Received November 4, 2010
Report
- Report Number
- 2648666-2010-00447
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 13, 2010
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GFF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT BEGAN TO FLAKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT METAL FLAKES FROM THE UNIT COVERED THE JOINT OF THE PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM 6 FLUTE ROUND BUR - HOLLOW, FORMULA (5BX) | BUR | GFF | STRYKER ENDOSCOPY PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |