MAUDE Adverse Event Report: CAYENNE MEDICAL CROSSFIX MENISCAL SYS CURVED; COMMON DEVICE NAME

Model Number N/A

Device Problem Misfire (2532)

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

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

Reference: (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that two crossfix devices misfired during a surgery.Surgeon decided to leave the meniscus as-is with no repair.No other patient harm or surgical delay was reported.

Event Description

It was reported that two crossfix devices misfired during a surgery.Surgeon decided to leave the meniscus as-is with no repair.No other patient harm or surgical delay was reported.

Manufacturer Narrative

Reference: (b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The root cause of this event is determined to be a possible use error, where the user torqued the dual needles during use.Dhr was reviewed and no discrepancies were found.A summary of the investigation will be 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.

• Brand Name: CROSSFIX MENISCAL SYS CURVED
• Type of Device: COMMON DEVICE NAME
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 8458365
• MDR Text Key: 140126873
• Report Number: 3006108336-2019-00024
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K121413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: N/A
• Device Catalogue Number: CM-8002
• Device Lot Number: 63371-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1