MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-03-25 for SAGITTAL BLADE 2108110000 manufactured by Stryker Ireland, Ltd..
[1435646]
It was reported that the packaging of product (b)(4) was tearing while opening the product which caused two blades to become unsterile potentially contaminating the sterile field. The procedure was completed successfully with a third blade. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8487633]
There were two lot numbers associated with this complaint (b)(4). The product has not yet been returned for evaluation. Based on the info provided by the sales rep, it can be assumed that product packaging associated with this event is damaged. An alternative packaging material has been implemented to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00213 |
| MDR Report Key | 1648730 |
| Report Source | 07 |
| Date Received | 2010-03-25 |
| Date of Report | 2010-02-24 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-02-24 |
| Device Manufacturer Date | 2007-08-13 |
| Date Added to Maude | 2010-12-13 |
| 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 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 | SAGITTAL BLADE |
| Generic Name | SAW BLADES AND ACCESSORIES |
| Product Code | DWH |
| Date Received | 2010-03-25 |
| Catalog Number | 2108110000 |
| Lot Number | 07225017 |
| Device Expiration Date | 2012-08-01 |
| Device Availability | N |
| 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 | 2010-03-25 |