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

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006108336-2022-00002
• Device Sequence Number: 20009337
• Product Code: MBI
• UDI-Device Identifier: 00887868270161
• UDI-Public: (01)00887868270161(17)230417(10)66685-2
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown