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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FEMURAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO FEMURAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6003-010-000
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/18/2017
Type of Reportable Event Malfunction
Event or Problem Description
During a surgical procedure conducted at the user facility a piece o the device disassembled.No patient involvement or procedural delays were associated with the event by the initial reporter.
 
Additional Manufacturer Narrative
The complaint was confirmed based on the device evaluation.Any physical impact to the navigated instrument can cause product damage.
 
Event or Problem Description
During a surgical procedure conducted at the user facility a piece of the device disassembled.No patient involvement or procedural delays were associated with the event by the initial reporter.
 
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Brand Name
FEMURAL TRACKER
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key6614842
Report Number0001811755-2017-01292
Device Sequence Number687561
Product Code OLO
UDI-Device Identifier04546540246011
UDI-Public(01)04546540246011
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K153240
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/07/2017
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 Model Number6003-010-000
Device Catalogue Number6003-010-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Initial Date Received by Manufacturer 05/18/2017
Supplement Date Received by Manufacturer06/26/2017
Initial Report FDA Received Date06/06/2017
Supplement Report FDA Received Date07/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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