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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5100004000
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 02/24/2014
Event Type  malfunction  
Event Description
The tps handpiece cord was returned to stryker instruments for service.During functional testing by a service technician, it was found that the device caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential to run without user activation.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
It was confirmed the cable caused a bias current error to be displayed by the service technician through functional evaluation.During the device inspection, a quality engineer determined the cable¿s internal wiring was damaged.The attachment is not a repairable device and will not be returned to the user facility.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Event Description
The tps handpiece cord was returned to stryker instruments for service.During functional testing by a service technician, it was found that the device caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential to run without user activation.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
TPS HANDPIECE CORD
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 Key3689971
MDR Text Key4226266
Report Number0001811755-2014-00961
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 02/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100004000
Device Lot Number06172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2006
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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