MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-13 for STERNUM BLADE 0298097101 manufactured by Stryker Ireland Ltd..
[19650231]
The blade subject to this investigation was not returned to the mfr for eval. Lot number info has not been provided to permit further investigation. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[19672266]
It was reported via the repair unit in (b)(6) that the broken blade was received in addition to other devices from the account. It is unk if there was any pt involvement of adverse consequences as a result of the broken blade. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616696-2012-00031 |
| MDR Report Key | 2460900 |
| Report Source | 07 |
| Date Received | 2012-02-13 |
| Date of Report | 2012-12-27 |
| Date of Event | 2012-12-27 |
| Date Mfgr Received | 2011-12-27 |
| Date Added to Maude | 2012-08-17 |
| 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 |
| Health Professional | 0 |
| 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 | 3532145329 |
| 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 |
| Product Code | DWH |
| Date Received | 2012-02-13 |
| Catalog Number | 0298097101 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-02-13 |