FDA Adverse Event
Malfunction
Summary report: N
4.0MM 6 FLUTE ROUND BUR - HOLLOW, FORMULA (5BX)
MDR report key: 2010320
·
Received February 11, 2011
Report
- Report Number
- 2648666-2011-00039
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 8, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, THE OUTER HOUSING ON THE UNIT FAILED. IT WAS FURTHER REPORTED THAT METAL FLAKES WERE GENERATED BY THE UNIT AND FELL INTO THE JOINT OF THE PT. IT IS POSSIBLE THAT THE FLAKES REMAINED IN THE PT. IT WAS FURTHER REPORTED THAT AN ADD'L 8-10 MINUTES OF ANESTHESIA WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM 6 FLUTE ROUND BUR - HOLLOW, FORMULA (5BX) | BUR | HRX | STRYKER ENDOSCOPY PUERTO RICO | 09079CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |