MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-02-12 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.
[3129593]
It was reported that during an aortic valve replacement surgery, the blade broke. It was also reported that there were no adverse consequences as a result of this event. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[10507429]
The returned blade was measured where possible and all critical specifications were met. Manufacturing records were reviewed, no issues were identified which may have contributed to this event. Investigation results indicate that the break potentially occurred due to prying or bending of the blade during use, but this cannot be confirmed. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[15098686]
It was reported that during an aortic valve replacement surgery, the blade broke. It was also reported that there were no adverse consequences as a result of this event. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[15292848]
The blade subject to this mdr was returned for evaluation. It was visually confirmed that the blade broke at the mount. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-00221 |
| MDR Report Key | 2956838 |
| Report Source | 04 |
| Date Received | 2013-02-12 |
| Date of Report | 2013-01-16 |
| Date of Event | 2013-01-16 |
| Date Mfgr Received | 2013-01-16 |
| Device Manufacturer Date | 2012-10-04 |
| Date Added to Maude | 2013-04-24 |
| 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. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL |
| 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 | 2013-02-12 |
| Returned To Mfg | 2013-02-08 |
| Catalog Number | 0298097100 |
| Lot Number | 12278027 |
| Device Expiration Date | 2017-10-01 |
| 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 | 2013-02-12 |