MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-28 for STERNUM BLADE 0298097100 manufactured by Stryker Ireland, Ltd..
[2873479]
Our sales rep uwe brill reported that during a surgery procedure a piece of the blade was broken off after the sternum blade guard was bent. The piece was fully removed from the pt. Because of this there was a delay of 30 mins. , a replacement was available and the surgery was successfully completed at the end.
Patient Sequence No: 1, Text Type: D, B5
[9997512]
The blade subject to this investigation was returned to the mfr for eval, it was visually confirmed the blade was broken along the shaft. The returned blade was measured where possible and all critical specifications were met. Lot number info has not been provided to permit further investigation. Investigation results indicate that the blade guard first became distorted due to prying which in turn put excessive pressure on the blade, which may have potentially caused the blade to break, however, this cannot be confirmed. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2012-00182 |
| MDR Report Key | 2646066 |
| Report Source | 01,07 |
| Date Received | 2012-06-28 |
| Date of Report | 2012-06-05 |
| Date of Event | 2012-06-04 |
| Date Mfgr Received | 2012-06-05 |
| Date Added to Maude | 2012-10-17 |
| 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 | 3 |
| 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 | STERNUM BLADE |
| Product Code | DWH |
| Date Received | 2012-06-28 |
| Returned To Mfg | 2012-06-15 |
| Catalog Number | 0298097100 |
| Lot Number | UNK |
| 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 | 2012-06-28 |