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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE SAG SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE SAG SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400034000
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/29/2020
Type of Reportable Event Malfunction
Event or Problem Description
The service technician reported that the device leaked during service testing at the user facility.There were no adverse consequences related to this event.
 
Event or Problem Description
The service technician reported that the device leaked during service testing at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Upon further review, the device catalog number was reported incorrectly in error.The catalog number has been correct, and this report is a duplicate of manufacturer report number 0001811755-2020-00382.
 
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Brand Name
CORE SAG SAW
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9694078
Report Number0001811755-2020-00449
Device Sequence Number1942342
Product Code ERL
UDI-Device Identifier04546540401953
UDI-Public04546540401953
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K112593
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) 04/24/2020
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 Number5400034000
Device Catalogue Number5400034000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 01/29/2020
Supplement Date Received by Manufacturer01/29/2020
Initial Report FDA Received Date02/11/2020
Supplement Report FDA Received Date04/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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