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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 Consequences Or Impact To Patient (2199)
Event Date 05/24/2016
Event Type  malfunction  
Event Description
It was reported that the tip of the device bent during a surgical procedure.No impact to the patient or delays were reported with this event.
 
Manufacturer Narrative
The reported event that the tip of the device was bent was confirmed through device inspection.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that the tip of the device bent during a surgical procedure.No impact to the patient or delays were reported with this event.
 
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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-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5728739
MDR Text Key47497466
Report Number0001811755-2016-00823
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 05/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2016
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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