MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-14 for CORE BLADE * 5400-134-283 manufactured by Styker Instruments, Instruments Division.
[4296551]
Saw blade broke during use on the sternum - stryker blade. Md note: during the division of the sternum, the saw blade of the stryker saw broke. Chest x-ray obtained at the end of the operation, with no fragment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3687299 |
| MDR Report Key | 3687299 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-03-14 |
| Date of Event | 2013-10-23 |
| Report Date | 2014-03-14 |
| Date Reported to FDA | 2014-03-14 |
| Date Reported to Mfgr | 2014-03-19 |
| Date Added to Maude | 2014-03-19 |
| 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 | CORE BLADE |
| Generic Name | SAW, ELECTRICALLY POWERED |
| Product Code | DWI |
| Date Received | 2014-03-14 |
| Model Number | * |
| Catalog Number | 5400-134-283 |
| Lot Number | 317030112083017K4 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STYKER INSTRUMENTS, INSTRUMENTS DIVISION |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-14 |