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 2016-09-12 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[54792167] A follow up report will be filed once the quality investigation is complete. Device discarded by customer.
Patient Sequence No: 1, Text Type: N, H10


[54792168] It was reported that during a osteotomy that the blade broke at the cutting end/teeth. It was also reported that there was a 5 minute delay to replace the blade 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


[63114400] The quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[63114401] It was reported that during a osteotomy that the blade broke at the cutting end/teeth. It was also reported that there was a 5 minute delay to replace the blade 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 Number0001811755-2016-02165
MDR Report Key5942340
Date Received2016-09-12
Date of Report2016-12-22
Date of Event2016-07-01
Date Mfgr Received2016-12-08
Date Added to Maude2016-09-12
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 NameUNKNOWN_INSTRUMENTSTIRE_PRODUCT
Generic NameUNKNOWN
Product CodeDWI
Date Received2016-09-12
Catalog NumberUNK_ICO
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2016-09-12

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