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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHO GRIP KNEE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO ORTHO GRIP KNEE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6003-012-000
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/06/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that at the user facility the device's accuracy was off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Additional Manufacturer Narrative
Additional information added for d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that at the user facility the device's accuracy was off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
ORTHO GRIP KNEE POINTER
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10779797
Report Number0001811755-2020-03031
Device Sequence Number3245998
Product Code HAW
UDI-Device Identifier04546540470331
UDI-Public04546540470331
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/25/2021
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 Model Number6003-012-000
Device Catalogue Number6003-012-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Initial Date Received by Manufacturer 10/06/2020
Supplement Date Received by Manufacturer03/24/2021
Initial Report FDA Received Date11/03/2020
Supplement Report FDA Received Date03/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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