FDA Adverse Event
Malfunction
Summary report: N
SURETAC GUIDE WIRES
MDR report key: 2202471
·
Received August 11, 2011
Report
- Report Number
- 1219602-2011-00130
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 26, 2011
- Report Date
- July 13, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY
- Product Code
- JDR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
DURING TIBIAL FIXATION OF ALLOGRAFT TISSUE A 9X20MM COATED INTERFERENCE SCREW WAS PASSED OVER A GUIDE WIRE WITH THE LEG HELD IN A 15 DEGREE OF FLEXION. SUBTLE VARUS MOVEMENT WAS UTILIZED WHEN GUIDING THE SCREW INTO PLACEMENT. THE GUIDE WIRE WAS REMOVED AND UPON INSPECTION, THE TIP OF THE GUIDE WIRE APPEARED TO HAVE BEEN SHEARED. A SIDE BY SIDE COMPARISON AGAINST A SIMILAR GUIDE WIRE CONFIRMED APPROXIMATELY 1CM WAS MISSING OF THE TIP. X-RAY AND FLUOROSCOPY WAS UTILIZED CONFIRMING 1CM PORTION OF THE GUIDE WIRE WAS SEEN ENTIRELY IN THE TIBIA BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURETAC GUIDE WIRES | SURETAC GUIDEWIRES,6MM, (6) | JDR | SMITH & NEPHEW ENDOSCOPY | 013353 | 50338150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |