FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE SMALL JOI
MDR report key: 2101229
·
Received May 24, 2011
Report
- Report Number
- 1219602-2011-00085
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 29, 2011
- Report Date
- April 29, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSOCPY MANSFIELD MANUFACTURE
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
METAL SHAVINGS APPEARED IN THE JOINT WHEN THE BLADE WAS INSERTED INTO THE JOINT AND TURNED ON BUT BEFORE ANY TISSUE WAS RESECTED. SURGEON STATED HE FELT THAT DEBRIS, REMAINING FROM THE MANUFACTURING PROCESS WAS THE POSSIBLE SOURCE OF THE SHAVINGS. SURGEON FLUSHED JOINT OF AS MUCH AS POSSIBLE BUT SOME METAL DEBRIS REMAINED. SURGEON CONCERNED AND UPSET AS HE CANNOT TAKE AN MRI OF THIS PATIENTS WRIST IN THE FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE SMALL JOI | FULL RADIUS,2.9,DSP,MINI BLD(6 | HAB | SMITH & NEPHEW ENDOSOCPY MANSFIELD MANUFACTURE | 3419 | 50552792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |