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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2015
Event Type  malfunction  
Event Description
It was reported that during inspection conducted at the user facility, the tip of the device broke off. No medical intervention and no adverse consequences were reported with this event. As this event occurred during inspection, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The reported event the tip of the device was broken off was confirmed through the visual inspection. Any physical impact to the navigated instrument can cause product damage. The device was scrapped.
 
Event Description
It was reported that during inspection conducted at the user facility the tip of the device broke off. No medical intervention and no adverse consequences were reported with this event. As this event occurred during inspection, 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 Key5375231
MDR Text Key36499229
Report Number0001811755-2016-00077
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 12/21/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2016
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 Manufacturer01/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2015
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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