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 2017-04-10 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[72653800] A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[72653801] It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece saw. 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


[74710986] A partial blade and the handpiece saw (7206000000 s/n;(b)(4)) subject to this investigation were returned to the manufacturer for evaluation. It was visually confirmed that the blade was broke. The returned partial blade part number is unknown. Investigation results indicate that there was a failure in the drive train of the associated handpiece, which could potentially cause the blade to break. The associated handpiece has been repaired and returned.
Patient Sequence No: 1, Text Type: N, H10


[74710987] It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece saw. 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 Number0001811755-2017-00841
MDR Report Key6478375
Date Received2017-04-10
Date of Report2017-05-09
Date of Event2017-03-15
Date Mfgr Received2017-05-04
Date Added to Maude2017-04-10
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 NameUNKNOWN
Product CodeDWI
Date Received2017-04-10
Returned To Mfg2017-02-20
Catalog NumberUNK_ICO
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
12147483647 2017-04-10

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