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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5120103015
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 1 devices were received for evaluation.Evaluation status: 2 events suggests the burs broke as a result of overload conditions.Additional information: 2 devices were labelled for single-use.2 devices were not reprocessed and reused.
 
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.There was no patient impact.
 
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Brand Name
1.5MM WIRE PASS DRILL BIT
Common Device Name
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8554339
Report Number0001811755-2019-01516
Device Sequence Number2260538
Product Code HBE
UDI-Device Identifier04546540077691
UDI-Public04546540077691
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) 04/26/2019
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 Number5120103015
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/01/2019
Initial Report FDA Received Date04/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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