MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-06-30 for STERNUM BLADE 0298097100 manufactured by Stryker Ireland Ltd..
[1634607]
It was reported that the saw blade snapped in half during a full sternotomy. It was further reported that both pieces were retrieved and the blade was accounted for in its entirety. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8603185]
The blade subject to this event has not been returned for eval. Lot no. Details are not available to assist further investigation. The root cause of this event is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00256 |
| MDR Report Key | 1746506 |
| Report Source | 00 |
| Date Received | 2010-06-30 |
| Date of Report | 2010-06-03 |
| Date of Event | 2010-05-18 |
| Date Mfgr Received | 2010-06-03 |
| Date Added to Maude | 2010-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | UNA BARRY |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Manufacturer Phone | 214532963 |
| Manufacturer G1 | STRYKER IRELAND LTD. |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERNUM BLADE |
| Generic Name | SAW BLADES AND ACCESSORIES |
| Product Code | DWH |
| Date Received | 2010-06-30 |
| Catalog Number | 0298097100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER IRELAND LTD. |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-30 |