MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-01 for INTERCONDYLAR FEMORAL CHISEL * manufactured by Depuy Orthopaedics, Inc..
[16638837]
During a surgical procedure, while the physician was using an intercondylar chisel deep in the patient's femoral canal, the 1/2 x 1 cm (estimated) spike at the end of the instrument broke off and fell distal. The physician was not able to extract the spike from the femoral canal. Piece was visualized on x-ray with results as follows: a single ap view of the distal right femur and right knee joint demonstrates a 2. 6 cm long metallic density projected over the distal right femoral diametaphysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1040872 |
| MDR Report Key | 1040872 |
| Date Received | 2008-05-01 |
| Date of Report | 2008-05-01 |
| Date of Event | 2008-03-17 |
| Report Date | 2008-05-01 |
| Date Reported to FDA | 2008-05-01 |
| Date Added to Maude | 2008-05-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCONDYLAR FEMORAL CHISEL |
| Generic Name | CHISEL, CEMENT, FEMORAL CANAL |
| Product Code | LZV |
| Date Received | 2008-05-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1008852 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPEDIC DRIVE WARSAW IN 46581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-01 |