STERNUM BLADE 0298097100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-26 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[81114566] A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[81114567] It was reported by the customer that the blade was broken inside the pack. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2017-01404
MDR Report Key6745000
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-07-26
Date of Report2018-02-14
Date of Event2017-06-30
Date Mfgr Received2018-02-14
Date Added to Maude2017-07-26
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 NameSTERNUM BLADE
Generic NameBLADE, SAW, SURGICAL, CARDIOVASCULAR
Product CodeDWH
Date Received2017-07-26
Returned To Mfg2017-07-12
Catalog Number0298097100
Lot NumberUNKNOWN
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 2017-07-26

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