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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE MICRO DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE MICRO DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400015000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/15/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
H3 other text : device not returned.
 
Event or Problem Description
The manufacturer service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
CORE MICRO 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 Key12676177
Report Number3015967359-2021-02194
Device Sequence Number4479829
Product Code ERL
UDI-Device Identifier04546540401939
UDI-Public04546540401939
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K943323
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) 11/04/2021
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 Model Number5400015000
Device Catalogue Number5400015000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/15/2021
Supplement Date Received by Manufacturer11/15/2021
Initial Report FDA Received Date10/21/2021
Supplement Report FDA Received Date11/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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