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 2016-04-21 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[44043129] A follow up report will be filed once the quality investigation is complete. Blade was discarded.
Patient Sequence No: 1, Text Type: N, H10


[44043130] It was reported that during preparation for a surgical procedure, it was noted that the blade broke in the head of the handpiece saw. It was also reported there were no delays and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[56579558] Investigation results for the concomitant device (6206000000, sn (b)(4)) reported the spherical bearing was found to be broken, which can affect device functionality and potentially cause or contribute to the blade break. The handpiece was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


[56579559] It was reported that during preparation for a surgical procedure, it was noted that the blade broke in the head of the handpiece saw. It was also reported there were no delays and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2016-00399
MDR Report Key5595846
Date Received2016-04-21
Date of Report2016-03-29
Date of Event2016-03-29
Date Mfgr Received2016-09-15
Date Added to Maude2016-04-21
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 NameUNKNOWN_INSTRUMENTSTIRE_PRODUCT
Generic NameUNKNOWN
Product CodeDWH
Date Received2016-04-21
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
10 2016-04-21

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