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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; BONE CUTTING INSTRUMENT AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; BONE CUTTING INSTRUMENT AND ACCESSORIES Back to Search Results
Catalog Number 5100088000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 10/07/2014
Event Type  malfunction  
Event Description
It was reported during repair the tps micro driver was found to be running in safe mode.No medical intervention and no adverse consequences were reported with this event.As this event occurred during repair, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The technician found that the device was running in safe mode, and noted a damaged pcb.The device was repaired and returned to the customer.
 
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Brand Name
TPS MICRO DRIVER
Type of Device
BONE CUTTING INSTRUMENT AND ACCESSORIES
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 Key4221782
MDR Text Key4971464
Report Number0001811755-2014-03932
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 10/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2014
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? Yes
Date Manufacturer Received10/07/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2000
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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