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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX CORING REAMER

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CAYENNE MEDICAL APERFIX CORING REAMER Back to Search Results
Device Problem Device Operates Differently Than Expected
Event Date 01/21/2011
Event Type  Malfunction  
Manufacturer Narrative

This report is being submitted late, due to an internal retrospective review. A follow up mdr will be submitted to provide the recall number.

 
Event Description

It was reported to cayenne medical that " the reamer used in a procedure backed out, and the teeth on the reamer flowered over. ".

 
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Brand NameAPERFIX
Type of DeviceCORING REAMER
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer Contact
shima hashemian
16597 n 92nd street
scottsdale , AZ 85260
4804582196
MDR Report Key7097734
Report Number3006108336-2017-00014
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 12/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown
Removal/Correction NumberTBD

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