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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER NAV3I(TM) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER NAV3I(TM) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 7700-800-000
Device Problems Device Handling Problem (3265); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility navigation equipment was unable to be registered and its use was canceled. The device had another patient's anatomy loaded which could cause an inaccuracy. The procedure was completed successfully without a clinically significant delay. No adverse consequences or medical intervention were reported.
 
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Brand NameSTRYKER NAV3I(TM) PLATFORM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key11738756
MDR Text Key248780642
Report Number3015967359-2021-00728
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7700-800-000
Device Catalogue Number7700-800-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
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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