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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX REAMER

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CAYENNE MEDICAL APERFIX REAMER Back to Search Results
Model Number CM-7110
Device Problem Device Operates Differently Than Expected
Event Type  Injury  
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 (b)(6) medical that "during an acl revision for aperfix, the tibial portion came out fine. The titanium pin of the aperfix femoral implant was removed with no issue. Ten (10) mm guide pin with stopper was placed and the 10mm coring reamer was run over the top. While reaming, it was observed that a lot of force was being used, and therefore; the reaming was stopped to check progress. When stopped, the first 15mm of the reamer was peeled back causing a little damage to the medial portion of the lateral condyle. The reamer was removed and no metal was left behind. ".

 
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Brand NameAPERFIX
Type of DeviceREAMER
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 Key7088801
Report Number3006108336-2017-00012
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 Received12/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCM-7110
Device Catalogue NumberCM-7110
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/10/2011
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberTBD

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