MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-16 for STERNUM BLADE 0298097101 manufactured by Stryker Ireland Ltd..
[18978858]
It was reported that during a surgical procedure, the blade broke and cut into the blade guard. It was also reported that there was no patient injury and there was no delays as a result of this event. It was further reported that the broken piece did not fall into the surgical site. It was also reported that another blade was available to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[19038824]
The blade subject to this mdr was returned for evaluation. It was visually confirmed that the blade broke along the shaft. The returned blade was measured where possible and all critical specifications were met. Lot number information has not been provided to permit further investigation. The root cause is undetermined. The handpiece associated with this mdr is as follows; part number: 6207000000, serial number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2012-00016 |
| MDR Report Key | 2435236 |
| Report Source | 06 |
| Date Received | 2012-01-16 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-20 |
| Date Mfgr Received | 2011-12-20 |
| Date Added to Maude | 2012-03-13 |
| 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 BERRY |
| 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, 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 | 2012-01-16 |
| Returned To Mfg | 2012-01-09 |
| Catalog Number | 0298097101 |
| Lot Number | UNK |
| 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 | 2012-01-16 |