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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 Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2016
Event Type  malfunction  
Event Description
It was reported that during equipment testing conducted by a service technician that the device displayed a bias current error, indicating a condition in which the device could unintentionally activate or run-on.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
 
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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 Key5771581
MDR Text Key48817321
Report Number0001811755-2016-01029
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 06/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2016
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 Manufacturer06/03/2016
Date Manufacturer Received06/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2002
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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