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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5400007000
Device Problem Device Remains Activated (1525)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/03/2017
Event Type  malfunction  
Event Description
The user facility reported that the device ran on during a procedure.The user facility reported that there were no medical interventions, surgical delay, or adverse consequences.
 
Manufacturer Narrative
Follow up being submitted for investigation results and additional information.
 
Event Description
The user facility reported that the device ran on during a procedure.The user facility reported that there were no medical interventions, surgical delay, or adverse consequences.
 
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Brand Name
NSE FOOTSWITCH
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6819770
MDR Text Key83612628
Report Number0001811755-2017-01777
Device Sequence Number1
Product Code DZJ
UDI-Device Identifier7613154879205
UDI-Public(01)7613154879205
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K040369
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 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400007000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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