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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 Unintended System Motion (1430)
Patient Problem No Patient Involvement (2645)
Event Date 05/13/2014
Event Type  malfunction  
Event Description
It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility, the tps handpiece cord was causing the handpiece 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
Upon visual inspection, the device was found to have evidence of third party repair.The device was discarded by the manufacturer.
 
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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 Key3850583
MDR Text Key15816393
Report Number0001811755-2014-02032
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 05/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100004000
Device Lot Number10040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2014
Date Manufacturer Received05/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2010
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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