MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-03-10 for MED NARROW BLD (25.0MM X5.5MM) 5400003414 manufactured by Stryker Ireland Ltd..
[1292639]
It was reported that a blade tooth broke off during a bunionectomy. It was further reported that it was not possible to retrieve the tooth from the pt and that an x-ray performed on the pt did not detect the presence of the tooth. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8444923]
The blade subject to this mdr was returned for eval. It was visually confirmed that a blade tooth had broken off. The root cause for this breakage has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00203 |
| MDR Report Key | 1634257 |
| Report Source | 07 |
| Date Received | 2010-03-10 |
| Date of Report | 2010-02-08 |
| Date of Event | 2010-02-08 |
| Date Mfgr Received | 2010-02-08 |
| Device Manufacturer Date | 2009-08-21 |
| Date Added to Maude | 2010-12-02 |
| 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 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 | MED NARROW BLD (25.0MM X5.5MM) |
| Generic Name | SAW BLADES AND ACCESSORIES |
| Product Code | DWH |
| Date Received | 2010-03-10 |
| Returned To Mfg | 2010-03-08 |
| Catalog Number | 5400003414 |
| Lot Number | 09233017 |
| Device Expiration Date | 2014-08-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2010-03-10 |