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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 Consequences Or Impact To Patient (2199)
Event Date 03/19/2015
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility, the tps microdriver kept running after the trigger was no longer depressed.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
 
Manufacturer Narrative
The reported event was not duplicated by service technician through functional testing.However, visual inspection of the device revealed corrosion on the sockets.
 
Event Description
It was reported that during a surgical procedure at the user facility, the tps microdriver kept running after the trigger was no longer depressed.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
 
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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 Key4686062
MDR Text Key20071321
Report Number0001811755-2015-01337
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 User Facility,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100088000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2000
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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