FDA Adverse Event
Injury
Summary report: N
VALOR(R) NAIL
MDR report key: 3230381
·
Received July 16, 2013
Report
- Report Number
- 1043534-2013-01141
- Event Type
- Injury
- Date Received
- July 16, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 14, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HSB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-01142, 01143.
Additional Manufacturer Narrative · 1
OTHER: COMPLAINT HISTORY REVIEWED.
Description of Event or Problem · 1
ALLEGEDLY IN USING THE HEX DRIVER TO COMPRESS THE NAIL DOWN, THE SURGEON COLD-WELDED THE COMPRESSION SCREW INSTEAD OF COMPRESSING THE NAIL. THIS EVENT CAUSED A 3-4 HOUR EXTENDED SURGERY TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330075 | VALOR(R) NAIL | SMALL JOINT COMPONENT, CODE:HSB | HSB | WRIGHT MEDICAL TECHNOLOGY, INC. | 099945833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |