MAUDE Adverse Event Report: CAYENNE MEDICAL VENTIX LINK KNTLS 5.5MM MACH; ANCHOR

Model Number N/A

Device Problems Fracture (1260); Separation Problem (4043)

Patient Problems Device Embedded In Tissue or Plaque (3165); Not Applicable (3189)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that anchor fractured when inserted into the patient.Fractured pieces remained in the patient bone.No other patient harm or surgical delay was reported.

Manufacturer Narrative

Reference: (b)(4).Correction: patient code updated to 3165.Device code updated to 4043.This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of the actual device.The anchor parts were separated and not fractured, and the tip of the anchor was not included.Since the other part of the implant was not returned, the exact root cause of this event cannot be determined.Dhr was reviewed and no discrepancies were found.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.

Manufacturer Narrative

Reference: (b)(4).Correction: patient code updated to 3165.Device code updated to 4043.This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of the actual device.The anchor parts were separated and not fractured, and the tip of the anchor was not included.Since the other part of the implant was not returned, the exact root cause of this event cannot be determined.Dhr was reviewed and no discrepancies were found.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 anchor fractured when inserted into the patient.Fractured pieces remained in the patient bone.No other patient harm or surgical delay was reported.

• Brand Name: VENTIX LINK KNTLS 5.5MM MACH
• Type of Device: ANCHOR
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 8542359
• MDR Text Key: 142871738
• Report Number: 3006108336-2019-00029
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K180274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2019
• Device Model Number: N/A
• Device Catalogue Number: 110025992
• Device Lot Number: 69381-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention