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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 Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2014
Event Type  malfunction  
Event Description
It was reported that during set up at the user 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.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event was not confirmed during the device evaluation and no other failures were detected.The device was discarded by the manufacturer.It was confirmed that the handpiece (core impaction drill 5400300000 ((b)(4))), which is listed had failures that may have caused or contributed to the reported event.However, as there are no hall sensors in this handpiece, a bias-current warning serves no preventative purpose in terms of run-on; therefore, a report will not be filed on the handpiece.
 
Event Description
It was reported that during set up at the user 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.The procedure was completed successfully.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 Key3802601
MDR Text Key4499413
Report Number0001811755-2014-01686
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,Followup
Report Date 04/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100004000
Device Lot Number13070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/12/2014
Initial Date FDA Received05/09/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2013
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 5400050000 ((B)(4)); CORE IMPACTION DRILL 5400300000 ((B)(4))
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