FDA Adverse Event
Malfunction
Summary report: N
LOGIC CRUCIATE RETAINING (CR)
MDR report key: 2904390
·
Received November 30, 2012
Report
- Report Number
- 1038671-2012-00140
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Date of Event
- October 19, 2012
- Report Date
- November 30, 2012
- Manufacturer
- EXACTECH INC.
- Product Code
- JWH
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DIMENSIONAL INVESTIGATION FOUND INTERFERENCE BETWEEN THE "BAT WING" TIP OF THE INSERT TRIAL AND THE FINAL TIBIAL TRAY IMPLANT, WHICH PREVENTED THE INSERT TRIAL FROM CORRECTLY SEATING. SURGICAL TECHNIQUE RECOMMENDS USE OF THE INSERT TRIAL WITH THE TRIBAL TRAY TRIAL DURING TRIALING AND USE OF THE FINAL INSERT AND TIBIAL TRAY IMPLANTS DURING CEMENTATION.
Description of Event or Problem · 1
SURGEON WAS IMPACTING THE POLY TIBIAL INSERT TRIAL INTO THE FINAL TIBIAL TRAY IMPLANT FOR CEMENT PRESSURIZATION AND CURING WHEN THE BACK CORNER OF THE INSERT TRIAL BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PT AND DISCHARGED WITH THE SURGICAL DRAPES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOGIC CRUCIATE RETAINING (CR) | TIBIAL INSERT TRIAL, SIZE 3.5 | JWH | EXACTECH INC. | 10200446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |