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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 Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Event or Problem Description
The distributor reported that the device overheated during procedure.There was no patient impact, no known delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The distributor reported that the device overheated during procedure.There was no patient impact, no known delay, no medical intervention, and no adverse consequences.
 
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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 Key9221270
Report Number0001811755-2019-03301
Device Sequence Number16857009
Product Code ERL
UDI-Device Identifier04546540401991
UDI-Public04546540401991
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 12/27/2019
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 Health Professional
Device Catalogue Number5400110000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Initial Date Received by Manufacturer 10/03/2019
Supplement Date Received by Manufacturer12/27/2019
Initial Report FDA Received Date10/22/2019
Supplement Report FDA Received Date12/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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