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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 07/25/2014
Event Type  malfunction  
Event Description
It was reported that the wires are showing on the footswitch at user facility.The event was found in the lab, no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that the wires are showing on the footswitch at user facility.The event was found in the lab, no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.After receiving at manufacturer facility it was found during service that bare wires were not exposed.
 
Manufacturer Narrative
The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.
 
Manufacturer Narrative
The reported event, of the cable being cut was confirmed during service evaluation.There were exposed wires; however, there were no exposed bare copper wires.Based on a review of the risk, and a review of the risk documents cut cables can be the result of handling.The device was not repairable.
 
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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 Key4027372
MDR Text Key4845194
Report Number0001811755-2014-02971
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
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 07/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2014
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 Manufacturer07/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2009
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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