MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-23 for ION NITRIDED BLADE 0940023000 manufactured by Stryker Ireland Ltd..
[20912941]
It was reported that while removing a fibreglass cast, the cast cutter blade broke at the mount. It was also reported that there was slight delay while replacing the blade. It was further reported that medical intervention was not required and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[21233349]
The cast cutter blade subject to this event was not returned to the mfr for eval. Lot number info has not been provided to permit further investigation. The ifu for the cast cutter blade has two warnings which states "ensure blade is properly seated in the cast cutter and the blade retaining nut is tightened before each use. An improperly tightened retaining nut may come loose causing blade to fracture, thereby endangering pt and user" and "excessive pressure, such as bending and prying with the blade, may cause the blade to fracture. " the root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2011-00139 |
| MDR Report Key | 2248069 |
| Report Source | 07 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-07-28 |
| Date of Event | 2011-07-08 |
| Date Mfgr Received | 2011-07-28 |
| Date Added to Maude | 2012-02-17 |
| 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 BERRY |
| 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 | ION NITRIDED BLADE |
| Product Code | LGH |
| Date Received | 2011-08-23 |
| Catalog Number | 0940023000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-08-23 |