FDA Adverse Event
Malfunction
Summary report: N
DARCO(R) LOCKING SCREW
MDR report key: 1980804
·
Received February 7, 2011
Report
- Report Number
- 1043534-2011-00052
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- December 9, 2010
- Report Date
- January 10, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HRS
- PMA / PMN Number
- K061808
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED FOR EVALUATION. CATALOG/LOT NUMBER NOT PROVIDED. COMPLAINT HISTORY REVIEWED AND ANALYSIS SHOWS NO TREND FOR ITEM/LOT. FUNCTIONAL TESTING SHOWS FAILURES DUE TO SCREWS BEING EXPOSED TO EXCESSIVE TORQUE DURING INSERTION.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY, THE SCREWS BROKE IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DARCO(R) LOCKING SCREW | SMALL JOINT COMPONENT | HRS | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |