MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-08-05 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.
[6081286]
It was reported that during a chest correction procedure, the blade broke in the blade guard. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[14314298]
The device is available for return. A follow up report will be filed once the quality investigation is complete. Device not yet returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[31967164]
The quality investigation is complete. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[31967165]
It was reported that during a chest correction procedure, the blade broke in the blade guard. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-02841 |
| MDR Report Key | 4972906 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-08-05 |
| Date of Report | 2015-07-10 |
| Date of Event | 2015-07-10 |
| Date Mfgr Received | 2015-11-11 |
| Date Added to Maude | 2015-08-05 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2015-08-05 |
| Catalog Number | 0298097100 |
| Lot Number | UNKNOWN |
| 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 | 2015-08-05 |