FDA Adverse Event
Malfunction
Summary report: N
POLARIS TORQUE INDICATING WRENCH
MDR report key: 930656
·
Received October 17, 2007
Report
- Report Number
- 2242816-2007-00051
- Event Type
- Malfunction
- Date Received
- October 17, 2007
- Date of Event
- October 10, 2007
- Report Date
- October 10, 2007
- Manufacturer
- EBI
- Product Code
- HXC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
TORQUE INDICATING WRENCHES ARE BREAKING DURING FINAL TORQUING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS TORQUE INDICATING WRENCH | HXC | EBI | 71743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |