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

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.

• Brand Name: FEMORAL RMV CORING REAMER 9MM
• Type of Device: APERFIX
• 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 Key: 8612494
• MDR Text Key: 145300126
• Report Number: 3006108336-2019-00032
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2014
• Device Model Number: N/A
• Device Catalogue Number: CM-7109ST
• Device Lot Number: 088K03511A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2011
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1