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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6003-011-000
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/15/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported during a service evaluation that the tip of the device was found broken off.There was no patient impact, medical intervention, or procedural delays.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported during a service evaluation that the tip of the device was found broken off.There was no patient impact, medical intervention, or procedural delays.
 
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Brand Name
POINTER, KNEE NAVIGATION
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8156823
Report Number0001811755-2018-02760
Device Sequence Number1579454
Product Code HAW
UDI-Device Identifier04546540246028
UDI-Public04546540246028
Combination Product (Y/N)N
PMA/510(K) Number
K993239
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 02/05/2019
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 Health Professional
Device Catalogue Number6003-011-000
Device Lot Number10475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Initial Date Received by Manufacturer 11/15/2018
Supplement Date Received by Manufacturer02/05/2019
Initial Report FDA Received Date12/12/2018
Supplement Report FDA Received Date02/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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