MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 2.9MM; FASTENER, FIXATION

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: part #: cm-9300, st 2.9mm gl drill, lot# 71241-1.Part #: cm-9129, quattro link anchor 2.9mm, lot#: 67061-2.Part #: cm-9129, quattro link anchor 2.9mm, lot#: 70603-2.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during surgery on the right side of the patient, the device came apart leaving the center rod stuck on the implant.Surgeon used a needle driver and mallet to remove and the implant came out on its own.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon investigation completion, it is now determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.

Event Description

Upon investigation completion, it is now determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.

• Brand Name: QUATTRO LINK ANCHOR 2.9MM
• Type of Device: FASTENER, FIXATION
• 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 ; 4805023661
• MDR Report Key: 13249988
• MDR Text Key: 283773577
• Report Number: 3006108336-2022-00002
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00887868270161
• UDI-Public: (01)00887868270161(17)230417(10)66685-2
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-9129
• Device Lot Number: 66685-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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
• Treatment: SEE H10