MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-12-08 for CORE INTRA-ORAL BLADE 5400031034 manufactured by Stryker Ireland Ltd..
[1788560]
It was reported that during an oral surgery in the mandibular ramus region, the blade broke at the weld between the blade and the shank. It was further reported that as a result of this breakage, a reciprocating blade was used to complete the procedure. The surgical technique was changed from a perpendicular osteotomy to horizontal osteotomy as a result. It was also reported that there was no pt injury and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[8813779]
The blade subject to this mdr was returned for eval. It was visually confirmed that the blade broke at the weld between the blade and the shank. The returned blade 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 | 9616696-2010-00366 |
| MDR Report Key | 1950141 |
| Report Source | 01,07 |
| Date Received | 2010-12-08 |
| Date of Report | 2010-11-11 |
| Date of Event | 2010-11-11 |
| Date Mfgr Received | 2010-11-11 |
| Device Manufacturer Date | 2010-06-18 |
| Date Added to Maude | 2012-01-18 |
| 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 | CORE INTRA-ORAL BLADE |
| Generic Name | SAW BLADES & ACCESSORIES |
| Product Code | DZH |
| Date Received | 2010-12-08 |
| Returned To Mfg | 2010-12-02 |
| Catalog Number | 5400031034 |
| Lot Number | 10169027 |
| Device Expiration Date | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-12-08 |