FDA Adverse Event
Malfunction
Summary report: N
ORTHOLOC(R) STAR DRIVER 7
MDR report key: 6096862
·
Received November 11, 2016
Report
- Report Number
- 1043534-2016-00119
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- November 4, 2016
- Report Date
- November 11, 2016
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HWR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
ALLEGEDLY, THE DRIVER BROKE DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748150 | ORTHOLOC(R) STAR DRIVER 7 | SMALL JOINT INSTRUMENT | HWR | WRIGHT MEDICAL TECHNOLOGY, INC. | 5202000016 | 1582087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |