STERNUM BLADE 0298097101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-21 for STERNUM BLADE 0298097101 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[33936150] Awaiting device evaluation. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[33936151] It was reported that during a surgical procedure on the chest, the blade broke at the mount. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


[44564779] The blade subject to this event was returned to the manufacturer for evaluation. It was visually confirmed that the blade was broken. The returned blade was measured where possible and all critical specifications were met. Tests performed on sample blades could not replicate the failure. A definitive root cause for the blade breakage cannot be determined in this case.
Patient Sequence No: 1, Text Type: N, H10


[44564780] It was reported that during a surgical procedure on the chest, the blade broke at the mount. It was also reported there were no delays and no adverse consequences 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 Number0001811755-2015-04649
MDR Report Key5313205
Report SourceOTHER
Date Received2015-12-21
Date of Report2015-12-01
Date of Event2015-11-27
Date Mfgr Received2016-04-29
Device Manufacturer Date2015-08-26
Date Added to Maude2015-12-21
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. DERVILLIA MURPHY
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 NameSTERNUM BLADE
Generic NameBLADE, SAW, SURGICAL, CARDIOVASCULAR
Product CodeDWH
Date Received2015-12-21
Returned To Mfg2015-12-14
Catalog Number0298097101
Lot Number15238017
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-21

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