FDA Adverse Event
Malfunction
Summary report: N
SMITH & NEPHEW
MDR report key: 1781606
·
Received July 22, 2010
Report
- Report Number
- MW5016857
- Event Type
- Malfunction
- Date Received
- July 22, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 22, 2010
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DEFECTIVE FOR DISPOSABLE INSTRUMENT 4.0 MM STONE CUTTER AND 5.0 MM INCISOR BLADE (B)(4) ARTHROSCOPIC SHAVER/BURR DURING USE RESULTED IN METAL FLAKING LEFT IN SHOULDER. SHOULDER SPACE IRRIGATED NO VISUAL RESIDUAL REMAINING. COMPANY NOTIFIED OF DEVICE FAILURE. DATE OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SLAP TEAR ON SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMITH & NEPHEW | ARTHROSCOPIC SURGERY BLADE, 5.0MM INCISOR BLADE | HRX | SMITH & NEPHEW, INC. | 20209475 | ||
| 2 | SMITH & NEPHEW | ARTHROSCOPIC SURGERY BLADE, 4.0MM STONE CUTTER | HRX | SMITH & NEPHEW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |