MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-04-06 for STERNUM BLADE 0298097101 manufactured by Stryker Ireland Ltd..
[1577214]
It was reported via the sales representative that the cutting teeth on the saw blade were turned in the wrong direction. It was also reported that the blade injured the patient by cutting into the patients pleura during a thoracotomy procedure. Pleural drainage had to be provided for the patient.
Patient Sequence No: 1, Text Type: D, B5
[8594972]
Device not returned to manufacturer for evaluation as yet. Lot number information has not been provided to permit further investigation. It was reported that the device allegedly involved in this event was reused. The label for the device has a symbol indicating "do not reuse". Investigation results indicate that the user did not follow instructions and re-used the blade which is a single use device. The investigation results also show that the orientation of the teeth of the blade has not been changed since its launch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00222 |
| MDR Report Key | 1654492 |
| Report Source | 01,07 |
| Date Received | 2010-04-06 |
| Date of Report | 2010-03-10 |
| Date of Event | 2010-03-10 |
| Date Mfgr Received | 2010-03-10 |
| Date Added to Maude | 2010-04-12 |
| 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 |
| Generic Name | SAW BLADES & ACCESSORIES |
| Product Code | DWH |
| Date Received | 2010-04-06 |
| Catalog Number | 0298097101 |
| Lot Number | UNKNOWN |
| 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. |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-06 |