MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-05-23 for STERNUM BLADE 0298097100 manufactured by Stryker Ireland Ltd., Instruments Division.
[17972021]
It was reported that during a sternotomy procedure, the blade broke at the cutting end. It was also reported that there was no adverse consequences as a result of this event. It was further reported that there was a delay of 15 minutes and a replacement blade was available.
Patient Sequence No: 1, Text Type: D, B5
[18053953]
The blade subject to this investigation was not returned to the mfr for eval. Mfr records were reviewed, no issues were identified which may have contributed to this event. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2012-00134 |
| MDR Report Key | 2588562 |
| Report Source | 01,06 |
| Date Received | 2012-05-23 |
| Date of Report | 2012-04-26 |
| Date of Event | 2012-04-18 |
| Date Mfgr Received | 2012-04-26 |
| Date Added to Maude | 2012-09-26 |
| 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 | 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, CO.CORK |
| Manufacturer Country | EI |
| Manufacturer Phone | 214532963 |
| Manufacturer G1 | STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CO.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 | 2012-05-23 |
| Catalog Number | 0298097100 |
| Lot Number | 11355017 |
| Device Expiration Date | 2016-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
| Manufacturer Address | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK CARRIGTWOHILL, CO.CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-23 |