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 0298097100 manufactured by Stryker Instruments-kalamazoo.
[4980742]
It was reported that the blade broke during a procedure. It was further reported that there was a 5 minute delay as a result. An x-ray was taken to ensure no piece was left behind. There was no patient impact or adverse consequences reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12546201]
The device was returned for evaluation. The quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[15182446]
It was reported that the blade broke during a procedure. It was further reported that there was a 5 minute delay as a result. An x-ray was taken to ensure no piece was left behind. There was no patient impact or adverse consequences reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15548073]
The device is available for return. A follow up report will be filed once the quality investigation is complete. Device not yet returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-02315 |
| MDR Report Key | 3902009 |
| Report Source | 06 |
| Date Received | 2014-06-30 |
| Date of Report | 2014-06-09 |
| Date of Event | 2014-06-09 |
| Date Mfgr Received | 2014-10-10 |
| 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 |
| Returned To Mfg | 2014-07-21 |
| Catalog Number | 0298097100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2014-06-30 |