MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK SP KNOTLESS ANCHOR; FASTENER, FIXATION

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2 : foreign : russia.The device was not reported to be returned for analysis; 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 that approximately 3 months after the anchor was implanted during achilles tendon fixation, the anchor was found migrated to talar sinus during post-op routine screening.The patient had pain and discomfort in the surgical area, and therefore the anchor was removed.Another device was not implanted during the revision.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: QUATTRO LINK SP KNOTLESS ANCHOR
• 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: jennifer rapsavage ; 56 e. bell dr; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19182487
• MDR Text Key: 341054044
• Report Number: 3006108336-2024-00012
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)270817(10)65536968
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K122314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9145SP
• Device Lot Number: 65536968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization