STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM) 6207097101

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number0001811755-2017-00835
MDR Report Key6471188
Report SourceHEALTH PROFESSIONAL
Date Received2017-04-07
Date of Report2017-04-07
Date of Event2017-03-10
Date Mfgr Received2017-03-12
Date Added to Maude2017-04-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. UNA BARRY
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer PostalNA
Manufacturer Phone214532900
Manufacturer G1STRYKER INSTRUMENTS-IRELAND
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM)
Generic NameBLADE, SAW, SURGICAL, CARDIOVASCULAR
Product CodeDWH
Date Received2017-04-07
Catalog Number6207097101
Lot NumberUNKNOWN
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-07

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