MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-18 for * 2108-382-2 manufactured by Stryker Instruments.
[20891218]
While using the saw to cut for total knee, the teeth broke off the saw blade. Two pieces retrieved from the field. X-rays were taken to ensure all pieces were retrieved. All x-rays were negative for foreign bodies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1029524 |
| MDR Report Key | 1029524 |
| Date Received | 2008-03-18 |
| Date of Report | 2008-03-18 |
| Date of Event | 2008-03-17 |
| Report Date | 2008-03-18 |
| Date Reported to FDA | 2008-03-18 |
| Date Added to Maude | 2008-04-17 |
| 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 |
| 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 | SAW BLADE, SAGITTAL |
| Product Code | DZH |
| Date Received | 2008-03-18 |
| Model Number | * |
| Catalog Number | 2108-382-2 |
| Lot Number | 08032017 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 996421 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-18 |