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

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Event or Problem Description
Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated:.Follow-up was made to update the patient information provided.Investigation is still in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: QUATTRO LINK SP KNOTLESS ANCHOR
• 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: jennifer rapsavage ; 56 e. bell dr; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19182487
• Report Number: 3006108336-2024-00012
• Device Sequence Number: 12570805
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)270817(10)65536968
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K122314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 07/30/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/13/2024; 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White