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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 01/03/2014
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the manufacturer facility the tps handpiece cord 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.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
During the device inspection, the quality engineer determined the cable¿s internal wiring was damaged since no other failures were found and a bias current error is an indication of a loss of electrical integrity.The device was discarded by the manufacturer.
 
Event Description
It was reported that during testing conducted at the manufacturer facility the tps handpiece cord 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.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
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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 Key3590554
MDR Text Key4249637
Report Number0001811755-2014-00259
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 01/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100004000
Device Lot Number12361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2012
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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