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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REAMER; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO REAMER; ARTHROSCOPE Back to Search Results
Catalog Number 4100231000
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Patient Involvement (2645)
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.Reported events: 1 event was reported for this quarter.Product return status: 1 device was received for evaluation.Evaluation status: 1 event was confirmed during testing; 1 device was found to be affected by wear.Product disposition: this device is not repairable and was not returned to the account.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
 
Event or Problem Description
This report summarizes 1 malfunction events in which the device had a component detach.There was no patient involvement; no patient impact.
 
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Brand Name
REAMER
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7714959
Report Number0001811755-2018-01281
Device Sequence Number19086544
Product Code HRX
UDI-Device Identifier04546540068224
UDI-Public04546540068224
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) 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 Number4100231000
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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