MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-22 for SAGITTAL BLADE 2108218000 manufactured by Stryker Ireland Ltd..
[1438092]
It was reported that the blade edges had perforated the sterile packaging. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8597003]
There were a number of items associated with this complaint. It can be confirmed from visual inspection that product packaging is damaged. Other complaints have been received reporting similar events. A secondary polybag has been introduced into the packaging configuration of these products to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00176 |
| MDR Report Key | 1625711 |
| Report Source | 07 |
| Date Received | 2010-02-22 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-07-20 |
| Date Mfgr Received | 2009-07-22 |
| Date Added to Maude | 2011-02-02 |
| 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 |
| 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 | SAGITTAL BLADE |
| Generic Name | SAW BLADES AND ACCESSORIES |
| Product Code | DWH |
| Date Received | 2010-02-22 |
| Catalog Number | 2108218000 |
| Lot Number | 09106027 |
| Device Expiration Date | 2014-04-01 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2010-02-22 |