MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-07-10 for STERNUM BLADE 0298097100 manufactured by Stryker Ireland Ltd..
[2815882]
It was reported that during a coronary artery bypass surgery, 3 sternum blades broke along the shaft. It was also reported that there was no adverse consequences as a result of this event. It was further reported that another blade was readily available and there was a few minutes delay to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10045121]
The 3 blades subject to this mdr were returned to the manufacturer for evaluation. It was visually confirmed that the 3 blades were broken along the shaft. Manufacturing records were reviewed, no issues were identified which may have contributed to this event. The root cause is undetermined. The blade guard associated with this mdr is as follows; part number: 4107008000, serial number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2012-00192 |
| MDR Report Key | 2657505 |
| Report Source | 01,06 |
| Date Received | 2012-07-10 |
| Date of Report | 2012-06-13 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2012-06-13 |
| Device Manufacturer Date | 2012-03-23 |
| Date Added to Maude | 2012-10-25 |
| 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, 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 |
| Product Code | DWH |
| Date Received | 2012-07-10 |
| Returned To Mfg | 2012-07-09 |
| Catalog Number | 0298097100 |
| Lot Number | 12083017 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER IRELAND LTD. |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-10 |