UNKNOWN_INSTRUMENTS_PRODUCT UNK_INS

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 2018-01-10 for UNKNOWN_INSTRUMENTS_PRODUCT UNK_INS manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[96813737] The user facility reported that during a surgical procedure, the device was running by itself. The user facility reported that the procedure was completed successfully without a delay, and that there were no adverse consequences or medical intervention. Attempts are currently being made to obtain additional information about the product from the user facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2018-00032
MDR Report Key7177845
Report SourceUSER FACILITY
Date Received2018-01-10
Date of Report2018-10-24
Date of Event2017-12-11
Date Mfgr Received2017-12-12
Date Added to Maude2018-01-10
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. ZACH BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN_INSTRUMENTS_PRODUCT
Generic NameDRIVER, WIRE, AND BONE DRILL, MANUAL
Product CodeDZJ
Date Received2018-01-10
Catalog NumberUNK_INS
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 2018-01-10

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