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 |