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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO U SERIES ELITE MEDIUM ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO U SERIES ELITE MEDIUM ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5100010452
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/31/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device overheated during testing conducted by a manufacturer field service technician at the user facility.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.The account did not return the device.
 
Event or Problem Description
It was reported the device overheated during testing conducted by a manufacturer field service technician at the user facility.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.
 
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Brand Name
U SERIES ELITE MEDIUM ANGLED ATTACHMENT
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 Key8344731
Report Number0001811755-2019-00565
Device Sequence Number19291109
Product Code ERL
UDI-Device Identifier04546540348425
UDI-Public04546540348425
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
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 Number5100010452
Device Lot Number18122
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/31/2019
Supplement Date Received by Manufacturer03/07/2019
Initial Report FDA Received Date02/15/2019
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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