FDA Adverse Event
Malfunction
Summary report: N
1043534-2012-01054
MDR report key: 2727097
·
Received September 5, 2012
Report
- Report Number
- 1043534-2012-01054
- Event Type
- Malfunction
- Date Received
- September 5, 2012
- Report Date
- August 27, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HWE
- PMA / PMN Number
- D091379
- Removal / Correction Number
- R12070001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: DEVICE FAILURE OCCURRED & WAS RELATED TO EVENT. THE COMPLAINT WAS REVIEWED. PHOTOGRAPHIC IMAGES WERE PROVIDED AND REVIEWED. THE PRODUCT WAS NOT RETURNED.
Additional Manufacturer Narrative · 1
THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE; HOWEVER, A VOLUNTARY RECALL HAS BEEN INITIATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01055.
Description of Event or Problem · 1
ALLEGEDLY, THERE WAS RUST ON THE REAMERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HWE | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |