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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT HANDSWITCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT HANDSWITCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400111000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/04/2019
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the handle is fractured off while it was being serviced at the manufacturer facility.The handle may break into small pieces, posing the risk of a small component becoming lost in a surgical site.There were no adverse consequences related to this event.
 
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Brand Name
CORE U-HT HANDSWITCH
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 Key8688460
Report Number0001811755-2019-01997
Device Sequence Number14208282
Product Code ERL
UDI-Device Identifier04546540402004
UDI-Public04546540402004
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
Report Date (Section B) 06/11/2019
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 Other
Device Catalogue Number5400111000
Device Lot Number16082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/04/2019
Initial Report FDA Received Date06/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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