BATTERY 4115000000

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 2016-01-29 for BATTERY 4115000000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[37094212] This report was reported in error under the alternative report number (b)(4) on (b)(4) 2013. The device was scrapped by stryker.
Patient Sequence No: 1, Text Type: N, H10


[37094213] It was reported that the system 4 battery allegedly overheated and emitted steam while charging at the user facility. The device was then returned to stryker instruments for evaluation where it was found to have externally and internally vented electrolytes. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2016-00111
MDR Report Key5398272
Report SourceUSER FACILITY
Date Received2016-01-29
Date of Report2013-05-06
Date of Event2013-05-06
Date Mfgr Received2013-05-06
Device Manufacturer Date2011-01-27
Date Added to Maude2016-01-29
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. CASEY METZGER
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 NameBATTERY
Generic NameINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Product CodeKIJ
Date Received2016-01-29
Returned To Mfg2013-05-31
Catalog Number4115000000
Lot Number11027
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 2016-01-29

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