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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE OSCILLATING SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE OSCILLATING SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400031000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events.4 events were reported for this quarter.Product return status.4 devices were received for evaluation.Evaluation status.2 events were confirmed during testing.2 devices were found to be affected by corrosion.2 events were not confirmed during testing; however: 2 devices were found to be affected by corrosion.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.
 
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Brand Name
CORE OSCILLATING SAW
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 Key8015059
Report Number0001811755-2018-02161
Device Sequence Number11108071
Product Code ERL
UDI-Device Identifier04546540401946
UDI-Public04546540401946
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized4
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/29/2018
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 Number5400031000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2018
Initial Report FDA Received Date10/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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