MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-12-09 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.
[16554549]
It was reported that during a surgical procedure an anatomical defect was noted when the saw hit a "knotty" area that torqued guides, this lead to the blade running off track and subsequently broke. It was also reported that all pieces were recovered. It was further reported that no injury occurred to patient or staff.
Patient Sequence No: 1, Text Type: D, B5
[16847506]
If the device is returned, an evaluation will be performed and a follow-up mdr will be submitted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[17565355]
It was reported that during a surgical procedure an anatomical defect was noted when the saw hit a "knotty" area that torqued guides, this lead to the blade running off track and subsequently broke. It was also reported that all pieces were recovered. It was further reported that no injury occurred to patient or staff.
Patient Sequence No: 1, Text Type: D, B5
[17758991]
If the blade is returned, an evaluation will be performed and a follow-up mdr will be submitted. Device not yet returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-03153 |
| MDR Report Key | 3505706 |
| Report Source | 00,06 |
| Date Received | 2013-12-09 |
| Date of Report | 2013-11-12 |
| Date of Event | 2013-09-18 |
| Date Mfgr Received | 2014-01-23 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2013-12-09 |
| 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 | RISK MANAGER |
| 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 | 2013-12-09 |
| Catalog Number | 0298097100 |
| Lot Number | 13182017 |
| Device Expiration Date | 2018-07-01 |
| 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 | 2013-12-09 |