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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE REAMER; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE REAMER; ARTHROSCOPE Back to Search Results
Catalog Number 4100235000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
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 - 2 events were reported for this quarter.  product return status - 2 devices were received for evaluation.  evaluation status - 1 reported event was confirmed during testing.- 1 device was found to be affected by broken and missing components.1 reported event was not confirmed during testing; the device was found to be within specifications.Additional information - 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.2 events had no patient involvement; no patient impact.
 
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Brand Name
HUDSON/MODIFIED TRINKLE REAMER
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8013985
Report Number0001811755-2018-01855
Device Sequence Number1395913
Product Code HRX
UDI-Device Identifier04546540068231
UDI-Public04546540068231
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) 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 Number4100235000
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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