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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PATIENT TRACKER, BLUE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO PATIENT TRACKER, BLUE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-010-000
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/26/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during equipment testing conducted at the user facility after the sterilization process the tip was found to be broken.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that during equipment testing conducted at the user facility after the sterilization process the tip was found to be broken.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
PATIENT TRACKER, BLUE
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8175853
Report Number0001811755-2018-02823
Device Sequence Number14151144
Product Code HAW
UDI-Device Identifier04546540392107
UDI-Public04546540392107
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K993239
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date (Section B) 02/07/2019
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
Operator of Device No Information
Device Catalogue Number6007-010-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Initial Date Received by Manufacturer 11/26/2018
Supplement Date Received by Manufacturer02/07/2019
Initial Report FDA Received Date12/18/2018
Supplement Report FDA Received Date02/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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