FDA Adverse Event
Malfunction
Summary report: N
ORTHOLOC(R) STAR DRIVER
MDR report key: 1970892
·
Received January 26, 2011
Report
- Report Number
- 1043534-2011-00021
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- December 17, 2010
- Report Date
- December 20, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HXX
- PMA / PMN Number
- A248163
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. EVIDENCE THAT PRODUCT WAS IN SPEC WHEN USED.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS IS BEING REPORTED AS A REPORTABLE MALFUNCTION. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY THE TIP OF THE DRIVER BROKE OFF WHILE LOCKING IN ONE OF THE SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOLOC(R) STAR DRIVER | SMALL JOINT INSTRUMENT | HXX | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |