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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
Catalog Number 5400034000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/03/2019
Type of Reportable Event Malfunction
Event or Problem Description
The device overheated during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
Event or Problem Description
The device overheated during a service evaluation at the manufacturer 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 0001811755-2019-02964.
 
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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 Key9087078
Report Number0001811755-2019-03022
Device Sequence Number2298537
Product Code ERL
UDI-Device Identifier04546540401960
UDI-Public04546540401960
Combination Product (Y/N)N
Initial Reporter StateMH
Initial Reporter CountryIN
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/19/2019
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 Other
Device Catalogue Number5400034000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 09/03/2019
Supplement Date Received by Manufacturer09/03/2019
Initial Report FDA Received Date09/19/2019
Supplement Report FDA Received Date11/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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