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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-008-000
Device Problem Disassembly (1168)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2016
Event Type  malfunction  
Event Description
It was reported that during the service evaluation conducted at the manufacturer facility, the button of the device was identified to be broken off.As the event was identified during service, there was no patient involvement or procedural delays.
 
Manufacturer Narrative
The reported event that the devices front button is broken off was confirmed through the device inspection.It was observed that the screw at the select button is loose causing the select button also to become loose.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that during the service evaluation conducted at the manufacturer facility, the button of the device was identified to be broken off.As the event was identified during service, there was no patient involvement or procedural delays.
 
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Brand Name
INSTRUMENT TRACKER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6159600
MDR Text Key62146177
Report Number0001811755-2016-02825
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022365
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 01/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6007-008-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2015
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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