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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.5MM X 12.0MM D-57 TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO 1.5MM X 12.0MM D-57 TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5400071057
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.The 2 events were reported for this quarter.The 2 events suggests the burs broke as a result of overload conditions.There were no remedial actions taken.This device is labelled for single-use.
 
Event or Problem Description
This report summarizes 2 malfunction events in which the device broke during use.There was patient involvement.Two events occurred during a cranial procedure while creating tack holes on a part of the skull on the back up table.There was no patient impact.
 
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Brand Name
1.5MM X 12.0MM D-57 TAPERED ROUTER
Common Device Name
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7714601
Report Number0001811755-2018-01196
Device Sequence Number1015398
Product Code HBE
UDI-Device Identifier04546540487445
UDI-Public04546540487445
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized2
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/24/2018
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 Number5400071057
Device Lot NumberE20015055
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2018
Initial Report FDA Received Date07/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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