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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 Patient Involvement (2645)
Date of Event 11/03/2018
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer field service technician reported that the device was overheating during testing at the user facility.There were no adverse consequences reported with this event.
 
Event or Problem Description
The manufacturer field service technician reported that the device was overheating during testing at the user facility.There were no adverse consequences reported with this event.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
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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 Key8121608
Report Number0001811755-2018-02606
Device Sequence Number264097
Product Code ERL
UDI-Device Identifier04546540401991
UDI-Public04546540401991
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) 04/17/2019
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 Number5400110000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Initial Date Received by Manufacturer 11/03/2018
Supplement Date Received by Manufacturer04/17/2019
Initial Report FDA Received Date11/30/2018
Supplement Report FDA Received Date04/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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