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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,
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STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; DRIVER, WIRE, AND BONE DRILL, Back to Search Results
Catalog Number 5100088000
Device Problem Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 02/15/2014
Event Type  malfunction  
Event Description
The tps micro driver was returned to stryker instruments for service, and during functional evaluation it was noted that the handpiece was running in safe mode.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
The reported event of running in safe mode was duplicated, and the technician noted a damaged printed circuit board (pcb) which can cause this failure.
 
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Brand Name
TPS MICRO DRIVER
Type of Device
DRIVER, WIRE, AND BONE DRILL,
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 Key3676656
MDR Text Key17260681
Report Number0001811755-2014-00865
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2014
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 Manufacturer02/18/2014
Date Manufacturer Received02/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/1999
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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