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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5100088000
Device Problem Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 03/23/2015
Event Type  malfunction  
Event Description
The tps micro driver was returned to stryker instruments for service.During functional testing by a service technician, it was found that the device ran in safe mode.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The reported event was duplicated by the service technician.The technician verified that the device ran in safe mode.Visual inspection revealed worn pc board.
 
Event Description
The tps micro driver was returned to stryker instruments for service.During functional testing by a service technician, it was found that the device ran in safe mode.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
TPS MICRO DRIVER
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4693858
MDR Text Key5669660
Report Number0001811755-2015-01381
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100088000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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