UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-05 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[101511260] A follow up report will be filed once the quality investigation is complete. Awaiting device return to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[101511261] It was reported that a blade was broken in the associated handpiece device. It was also reported that there was no patient involvement, no delay, no medical intervention, and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2018-00474
MDR Report Key7312565
Report SourceUSER FACILITY
Date Received2018-03-05
Date of Report2018-04-13
Date of Event2018-01-19
Date Mfgr Received2018-04-12
Date Added to Maude2018-03-05
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 NameUNKNOWN_INSTRUMENTSTIRE_PRODUCT
Generic NameBLADE, SAW, SURGICAL, CARDIOVASCULAR
Product CodeDWH
Date Received2018-03-05
Catalog NumberUNK_ICO
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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
12147483647 2018-03-05

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