MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-19 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.
[3543509]
It was reported that during a sternum procedure, the blade broke in two pieces. It was also reported that a broken piece fell into the patient; it was located 2cms from the heart and was removed. It was further reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[3846006]
It was reported that during a sternum procedure, the blade broke in two pieces. It was also reported that a broken piece fell into the patient; it was located 2cms from the heart and was removed. It was further reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[10849291]
The blade subject to this mdr was not returned to the manufacturer for evaluation. If the product is returned, a follow-up mdr will be submitted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[11315487]
The exact root cause cannot be determined. However investigation results indicate that the crack originated at the bottom of the last tooth. The possible cause is overloading of the blade during the surgery, but this cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-01431 |
| MDR Report Key | 3178142 |
| Report Source | 05 |
| Date Received | 2013-06-19 |
| Date of Report | 2013-05-27 |
| Date of Event | 2013-05-22 |
| Date Mfgr Received | 2013-11-05 |
| Device Manufacturer Date | 2013-03-12 |
| Date Added to Maude | 2013-06-19 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 2013-06-19 |
| Returned To Mfg | 2013-06-24 |
| Catalog Number | 0298097100 |
| Lot Number | 13071017 |
| Device Expiration Date | 2018-03-01 |
| 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 | 2013-06-19 |