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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 01/30/2014
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 runs in safe mode.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.
 
Event Description
The tps micro driver was returned to stryker instruments for service, and during functional evaluation it was noted that the handpiece runs 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 which can cause this failure.Based on a review of the device ifu and the device repair history, the damage is likely a result of the age of the device.
 
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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 Key3626343
MDR Text Key4176898
Report Number0001811755-2014-00469
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,Followup
Report Date 01/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2014
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 Manufacturer01/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/21/1999
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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