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 UNK STERNUM BLADE manufactured by Stryker Ireland, Ltd..
[2873482]
It was reported that during a sternotomy procedure, the sternum blade guard bent during sawing and a piece of blade broke. It was also reported that surgery was delayed by 30 mins and the broken piece was removed from the surgical site. It was further reported that a replacement was available and the surgery was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
[9997517]
The blade subject to this investigation was not returned to the mfr for eval. Part number and lot number info has not been provided to permit further investigation. The blade guard was returned for investigation, visual inspection confirmed that the blade guards were severely bent. Investigation results indicate that lateral stress may have been placed on the foot of the guard, which may have potentially caused the blade to break, however, this cannot be confirmed. The root cause is undetermined. The blade guards associated with this mdr are as follows; part number: 7207003000, serial number: (b)(4), part number: 7207003000, serial number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2012-00181 |
| MDR Report Key | 2646041 |
| Report Source | 01,07 |
| Date Received | 2012-06-28 |
| Date of Report | 2012-06-05 |
| Date of Event | 2012-06-03 |
| 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 | UNK STERNUM BLADE |
| Product Code | DWH |
| Date Received | 2012-06-28 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | N |
| 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 | 2012-06-28 |