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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400110000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Information (3190)
Date of Event 01/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated, although requested, no information was available regarding patient involvement, adverse consequences, surgical delay or medical intervention.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device overheated, although requested, no information was available regarding patient involvement, adverse consequences, surgical delay or medical intervention.
 
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Brand Name
CORE U-HT DRILL
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 Key8324469
Report Number0001811755-2019-00543
Device Sequence Number70951
Product Code ERL
UDI-Device Identifier04546540401991
UDI-Public04546540401991
Combination Product (Y/N)N
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) 03/11/2019
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 No Information
Device Catalogue Number5400110000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Initial Date Received by Manufacturer 01/15/2019
Supplement Date Received by Manufacturer03/11/2019
Initial Report FDA Received Date02/09/2019
Supplement Report FDA Received Date03/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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