MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-17 for STERNUM BLADE 0298097101 manufactured by Stryker Instruments-kalamazoo.
[33701440]
Awaiting device evaluation. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[33701441]
It was reported that after the surgeon performed a cut to the patient's breastbone, it was noted that the blade broke at the mount. It was also reported that the broken fragment was found on the patient's chest and was immediately removed. 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
[45289147]
The sternum blade subject to this investigation was returned to the manufacturer for evaluation. It was visually confirmed that the blade was broken. Investigation results indicate that the break observed in the returned blade could not be replicated with or without using a sternum guard. A definitive root cause for the blade breakage cannot be determined in this case.
Patient Sequence No: 1, Text Type: N, H10
[45289148]
It was reported that after the surgeon performed a cut to the patient's breastbone, it was noted that the blade broke at the mount. It was also reported that the broken fragment was found on the patient's chest and was immediately removed. 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 | 0001811755-2015-04568 |
| MDR Report Key | 5305337 |
| Report Source | OTHER |
| Date Received | 2015-12-17 |
| Date of Report | 2015-11-25 |
| Date of Event | 2015-09-25 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2015-12-17 |
| 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 | 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 | 2015-12-17 |
| Returned To Mfg | 2015-12-15 |
| Catalog Number | 0298097101 |
| Lot Number | 15238017 |
| 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 | 2015-12-17 |