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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 Remains Activated (1525)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2014
Event Type  malfunction  
Event Description
It was reported the during a procedure the tps handpiece cord caused the handpiece to run without user activation after the trigger was released.The procedure was completed successfully utilizing the same device.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
During the device evaluation, the technician determined the cable¿s internal wiring was damaged.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 Key3943453
MDR Text Key4642708
Report Number0001811755-2014-02568
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100004000
Device Lot Number11321
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2014
Date Manufacturer Received06/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CORE CONSOLE (B)(4); CORE UNIVERSAL DRIVER (B)(4)
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