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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM PRECISION NEURO (MATCH HEAD); DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO 3.0MM PRECISION NEURO (MATCH HEAD); DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5820107530
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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 e2015055.1 event was reported for this quarter.1 event suggests the device broke as a result of overload conditions.Additional information : 1 device is labelled for single-use.1 device was not reprocessed and reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device broke during a posterior spinal fusion revision surgical procedure.There was patient involvement.There was no patient impact.
 
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Brand Name
3.0MM PRECISION NEURO (MATCH HEAD)
Common Device Name
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8001717
Report Number0001811755-2018-01779
Device Sequence Number13736029
Product Code HBE
UDI-Device Identifier07613154028177
UDI-Public07613154028177
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/24/2018
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 Number5820107530
Device Lot NumberE2015055
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 Date10/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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