MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-13 for ION NITRIDED BLADE 0940023000 manufactured by Stryker Ireland Ltd.,.
[2222675]
It was reported that the cast cutter blade broke at the mount while fitting it to the handpiece. It was also reported that there was no pt involvement as a result of this event. No further info has been provided.
Patient Sequence No: 1, Text Type: D, B5
[9374152]
The cast cutter blade associated with this event was returned to the mfr for eval. It was visually confirmed that the blade broke at the mount. The returned blade was measured where possible and all critical specs were met. Mfg records were reviewed, no issues were identified which may have contributed to this event. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2011-00189 |
| MDR Report Key | 2314394 |
| Report Source | 06 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-09-16 |
| Date Mfgr Received | 2011-09-16 |
| Device Manufacturer Date | 2010-12-03 |
| Date Added to Maude | 2012-02-27 |
| 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, CO.CORK |
| Manufacturer Country | EI |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CO.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 | 2011-10-13 |
| Returned To Mfg | 2011-10-05 |
| Catalog Number | 0940023000 |
| Lot Number | 10337017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER IRELAND LTD., |
| Manufacturer Address | CARRIGTWOHILL, CO.CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-13 |