UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[144955345] A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[144955346] It was reported that during testing of the blade, it was noted that the blade broke where it fits into the handpiece. It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2019-01598
MDR Report Key8588329
Date Received2019-05-07
Date of Report2019-06-19
Date of Event2019-04-09
Date Mfgr Received2019-06-12
Device Manufacturer Date2018-11-12
Date Added to Maude2019-05-07
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 ContactMRS. 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 Report0

Device Details

Brand NameUNKNOWN_INSTRUMENTSTIRE_PRODUCT
Generic NameUNKNOWN
Product CodeDWI
Date Received2019-05-07
Returned To Mfg2019-04-12
Catalog NumberUNK_ICO
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2019-05-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.