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U.S. Department of Health and Human Services

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

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STRYKER INSTRUMENTS-KALAMAZOO LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-011-000
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2013
Event Type  malfunction  
Event Description
It was reported that the tip of the large pointer was bent during testing at the user facility.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
The reported event that the pointer tip was bent was duplicated; during visual inspection it was confirmed that the device had a bent tip.The pointer could be validated and used for navigation despite the visual damage.It is possible that bending forces caused the tip to bend.The pointer was repaired and put back into stryker stock.
 
Event Description
It was reported that the tip of the large pointer was bent during testing at the user facility.There was no patient involvement and no adverse consequences associated with the device.
 
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Brand Name
LARGE POINTER
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-79 111
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3571776
MDR Text Key4446886
Report Number0001811755-2014-00127
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 Other
Type of Report Initial,Followup
Report Date 12/18/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/03/2014
Initial Date FDA Received01/13/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/20/2014
Was Device Evaluated by Manufacturer? No
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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