MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-07 for STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM) 6207097101 manufactured by Stryker Instruments-kalamazoo.
[72096569]
The quality investigation is complete. Blade not available for return.
Patient Sequence No: 1, Text Type: N, H10
[72096570]
It was reported that during a surgical procedure, the sternum blade guard bent while cutting the sternum and the blade broke. It was also reported that there were no adverse consequences and no delays 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 | 0001811755-2017-00835 |
MDR Report Key | 6471188 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2017-04-07 |
Date of Report | 2017-04-07 |
Date of Event | 2017-03-10 |
Date Mfgr Received | 2017-03-12 |
Date Added to Maude | 2017-04-07 |
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. UNA BARRY |
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 | STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM) |
Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
Product Code | DWH |
Date Received | 2017-04-07 |
Catalog Number | 6207097101 |
Lot Number | UNKNOWN |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
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 | 2017-04-07 |