MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-01-07 for OSCILLATING AND SAGITTAL BLADE 2296003111 manufactured by Stryker Ireland Ltd..
[1900845]
It was reported that at the end of a surgical procedure, where the mandible bone was being cut, it was noted that the blade was broken at the mount. It was also reported that the broken pieces did not fall into the surgical site. It was further reported that there was no pt or user injury and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[8859908]
The blade and the broken piece subject to this mdr were returned for eval. It was visually confirmed that the blade was broken at the mount. The returned blade was measured where possible and all critical specifications were met. Lot number info has not been provided to permit further investigation. The root cause undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2011-00003 |
| MDR Report Key | 1985570 |
| Report Source | 01,07 |
| Date Received | 2011-01-07 |
| Date of Report | 2010-12-13 |
| Date of Event | 2010-11-30 |
| Date Mfgr Received | 2010-12-13 |
| Date Added to Maude | 2011-03-22 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | OSCILLATING AND SAGITTAL BLADE |
| Generic Name | SAW BLADES & ACCESSORIES |
| Product Code | DWH |
| Date Received | 2011-01-07 |
| Returned To Mfg | 2011-12-17 |
| Catalog Number | 2296003111 |
| Lot Number | UNK |
| 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 | 2011-01-07 |