TPS MICRO DRIVER 5100088000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-06-22 for TPS MICRO DRIVER 5100088000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[5851920] It was reported that during sterilization at the user facility, the trigger of the tps micro driver is sticking. As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5


[25949119] The reported event of sticking trigger was duplicated. Through visual evaluation, the technician observed both a non-stryker gasket and non-stryker motor. Disassembly of the device revealed both wear and corrosion on the trigger shaft. The trigger assembly and non-conforming parts were replaced, device passed final inspection, and was returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


[25949120] It was reported that during sterilization at the user facility, the trigger of the tps micro driver is sticking. As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2015-02249
MDR Report Key4858423
Report Source06,USER FACILITY
Date Received2015-06-22
Date of Report2015-06-01
Date of Event2015-06-01
Date Mfgr Received2015-09-16
Device Manufacturer Date2005-03-04
Date Added to Maude2015-06-22
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 NameTPS MICRO DRIVER
Generic NameDRIVER, WIRE, AND BONE DRILL, MANUAL
Product CodeDZJ
Date Received2015-06-22
Returned To Mfg2015-06-05
Catalog Number5100088000
Device AvailabilityR
Device AgeDA
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 2015-06-22

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