MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-15 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-ireland.
[4139877]
It was reported that during a surgical procedure, the sternum blade and the sternum blade guard broke. It was also reported that the fragments were removed from the patient? S body. It was further reported that there was a ten minute surgical delay; x-rays were taken to ensure no fragments were left. It was further reported that the procedure was completed successfully using an alternative sagittal handpiece saw and a sagittal blade.
Patient Sequence No: 1, Text Type: D, B5
[4341345]
It was reported that during a surgical procedure, the sternum blade and the sternum blade guard broke. It was also reported that the fragments were removed from the patient? S body. It was further reported that there was a ten minute surgical delay; x-rays were taken to ensure no fragments were left. It was further reported that the procedure was completed successfully using an alternative sagittal handpiece saw and a sagittal blade.
Patient Sequence No: 1, Text Type: D, B5
[11556353]
The device evaluation is anticipated, but not yet begun. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[11638867]
Device evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-00148 |
| MDR Report Key | 3575712 |
| Report Source | 07 |
| Date Received | 2014-01-15 |
| Date of Report | 2013-12-17 |
| Date of Event | 2013-12-16 |
| Date Mfgr Received | 2014-03-04 |
| Date Added to Maude | 2014-01-15 |
| 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 | 2014-01-15 |
| Returned To Mfg | 2014-01-02 |
| 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-IRELAND |
| Manufacturer Address | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK CARRIGTWOHILL MI 49001NA 49001 NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2107000000 | 1. Other | 2014-01-15 |