MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-17 for * 200-1003 manufactured by Segway Orthopaedics.
[4603480]
While using the segway retrograde ligament knife, the end broke off inside the patient's right foot. Using a scope and flouroscopy, it was determined that all pieces were retrieved from the patient's foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3943337 |
| MDR Report Key | 3943337 |
| Date Received | 2014-06-17 |
| Date of Report | 2014-06-17 |
| Date of Event | 2014-06-06 |
| Report Date | 2014-06-17 |
| Date Reported to FDA | 2014-06-17 |
| Date Reported to Mfgr | 2014-07-18 |
| Date Added to Maude | 2014-07-18 |
| 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 | 3 |
| 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 | * |
| Generic Name | KNIFE, ORTHOPEDIC |
| Product Code | HTS |
| Date Received | 2014-06-17 |
| Model Number | 200-1003 |
| Catalog Number | * |
| Lot Number | 1061401 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEGWAY ORTHOPAEDICS |
| Manufacturer Address | 5205 AVENIDA ENCINAS STE C CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-17 |