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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
Model Number CM-7109ST
Device Problems Use of Device Problem (1670); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2017
Event Type  malfunction  
Event Description
It was reported to cayenne medical that " the coring reamer teeth bent outwards during acl revision.A second reamer had to be used." the reason for revision was not reported.
 
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Brand Name
APERFIX
Type of Device
CORING REAMER
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
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 Key7130532
MDR Text Key95825712
Report Number3006108336-2017-00016
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2018
Device Model NumberCM-7109ST
Device Catalogue NumberCM-7109ST
Device Lot Number51153-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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