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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 Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2017
Event Type  malfunction  
Event Description
The user facility reported that this device was causing a run-on event.The user facility was not able to supply any further information regarding the reported event.
 
Manufacturer Narrative
Added information from device investigation.
 
Event Description
The user facility reported that this device was causing a run-on event.The user facility was not able to supply any further information regarding the reported event.
 
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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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6699192
MDR Text Key79577076
Report Number0001811755-2017-01370
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
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 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
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 Manufacturer06/15/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2016
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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