FDA Adverse Event
Malfunction
Summary report: N
PROFEMUR(R) NECK EXTRACTOR T-HANDLE
MDR report key: 2072108
·
Received April 28, 2011
Report
- Report Number
- 1043534-2011-00168
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 18, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT CONTRIBUTED TO EVENT.VISUALLY EXAMINED. COMPLAINT REVIEWED.
Additional Manufacturer Narrative · 1
THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY THE INSTRUMENT STRIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) NECK EXTRACTOR T-HANDLE | HIP INSTRUMENT | LXH | WRIGHT MEDICAL TECHNOLOGY, INC. | 345258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |