MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-12 for * manufactured by Stryker Instruments.
[4573538]
The surgical resident was using the saw and trying to turn the saw rather acutely to cut in a curving fashion but turned too quickly which led to the blade breaking. There was no harm to the patient and the broken piece immediately removed from the field. Http://www. Stryker. Com/stellent/groups/public/documents/web_prod/007117. Pdf. This is the company brochure for this product. ======================manufacturer response for stryker sternal saw, (brand not provided) (per site reporter). ======================the operating room (or) contacted the manufacturer representative and the saw and drill were provided to the representative for the company to review. The company has all of the identifying information, so no lot number or drill number is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3940481 |
| MDR Report Key | 3940481 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-06-12 |
| Date of Event | 2014-06-10 |
| Report Date | 2014-06-12 |
| Date Reported to FDA | 2014-06-12 |
| Date Reported to Mfgr | 2014-07-17 |
| Date Added to Maude | 2014-07-17 |
| 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 | 3 |
| 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 | STERNAL SAW |
| Product Code | DWI |
| Date Received | 2014-06-12 |
| Returned To Mfg | 2014-06-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-12 |