• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL FEMORAL RMV CORING REAMER 9MM APERFIX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAYENNE MEDICAL FEMORAL RMV CORING REAMER 9MM APERFIX Back to Search Results
Model Number N/A
Device Problem Material Fragmentation
Event Date 05/13/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This report is being submitted late, due to an internal retrospective review. Product has been received by zimmer biomet and the investigation is complete. Complaint sample was evaluated and the reported event was confirmed. It is possible that the reamer was damaged due to the off-axis use in the tunnel. Dhr was reviewed, and no anomalies were noted. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that aperfix coring reamer device has malfunctioned during surgery. Metal shaving may have remained inside the patient. No other patient harm or significant surgical delay was reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMORAL RMV CORING REAMER 9MM
Type of DeviceAPERFIX
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
101
scottsdale AZ 85260
Manufacturer (Section G)
LSO
830 challanger st
brea CA 92821
Manufacturer Contact
shima hashemian
16597 n 92nd street
101
scottsdale , AZ 85260
4805023661
MDR Report Key8612494
Report Number3006108336-2019-00032
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 05/13/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/04/2014
Device MODEL NumberN/A
Device Catalogue NumberCM-7109ST
Device LOT Number088K03511A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/13/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/04/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

-
-