MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-30 for STERNUM BLADE 0298097101 manufactured by Stryker Instruments-kalamazoo.
[4675728]
It was reported that the blade was extending past the sternum blade guard during set up. It was further reported that the blade broke and was discarded. There was no adverse consequences or surgical delay reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[4762974]
It was reported that the blade was extending past the sternum blade guard during set up. It was further reported that the blade broke and was discarded. There was no adverse consequences or surgical delay reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12028376]
The device is not available for return. A follow up report will be filed once the quality investigation is complete. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[12373977]
The device was not returned. The quality investigation is complete. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-02313 |
| MDR Report Key | 3902003 |
| Report Source | 06 |
| Date Received | 2014-06-30 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-01-28 |
| Date Mfgr Received | 2014-08-23 |
| Date Added to Maude | 2014-06-30 |
| 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 | MR. DERVILLIA MURPHY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERNUM BLADE |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2014-06-30 |
| Catalog Number | 0298097101 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-30 |