MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-08-12 for SAGITTAL BLADE-STERNUM REVISION 2108137000 manufactured by Stryker Ireland Ltd..
[2328887]
It was reported that during a sternotomy procedure the blade broke. It was also reported the procedure was delayed and there was a potential for vascular and visceral injuries for the patient. It was further reported that another blade was used to complete the surgery. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[9403880]
The blade subject to this investigation was not returned to the manufacturer for evaluation. Manufacturing 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 | 9616696-2011-00136 |
| MDR Report Key | 2227256 |
| Report Source | 01,06 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-07-18 |
| Date of Event | 2011-06-28 |
| Date Mfgr Received | 2011-07-18 |
| Device Manufacturer Date | 2011-01-27 |
| Date Added to Maude | 2011-10-25 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| 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 | 214532963 |
| Manufacturer G1 | STRYKER IRELAND LTD. |
| 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 | SAGITTAL BLADE-STERNUM REVISION |
| Product Code | DWH |
| Date Received | 2011-08-12 |
| Catalog Number | 2108137000 |
| Lot Number | 11027017 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2011-08-12 |