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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-012-000
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 01/07/2016
Event Type  malfunction  
Event Description
It was reported that the tip of the device was broken off during testing conducted at the user facility. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The reported event that the tip of the device was broken off was confirmed through the visual inspection. Any physical impact to the navigated instrument, such as with a mallet or a similar tool can cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that the tip of the device was broken off during testing conducted at the user facility. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
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Brand NameSMALL POINTER
Type of DeviceNEUROLOGICAL 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 Key5403715
MDR Text Key37540092
Report Number0001811755-2016-00120
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6000-012-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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