MAUDE Adverse Event Report: CAYENNE MEDICAL VENTIX LINK KNTLS 4.75MM MACH; FASTENER, FIXATION

Catalog Number	110025990
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the anchor was removed approximately 3 months after initial implantation due to ongoing pain and a palpable prominence consistent with the anchor location suggesting a partially dislodged anchor.The anchor that was backing out was removed via a second arthroscopic procedure.The cuff tissue was found to be well healed and so there was no need for additional anchor fixation, just removal of the previous anchor implant that had started to back out.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the anchor backed out post-implantation and was removed approximately 3 months later due to ongoing pain and a palpable prominence consistent with the anchor location.The backing-out anchor was removed via a second arthroscopic procedure.Intra-operative findings noted the cuff tissue was well healed, and no additional anchor fixation was performed.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: h2; h3; h4; h6; h11.The reported event could not be confirmed due to lack of product/information.Visual examination of the provided photo identifies the anchor.Warping can be seen by the eyelet but this cannot be confirmed from the single photo.No product was returned or additional pictures provided; further visual and dimensional evaluations could not be performed.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VENTIX LINK KNTLS 4.75MM MACH
• 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: 22723041
• Report Number: 3006108336-2025-00029
• Device Sequence Number: 21248754
• Product Code: MBI
• UDI-Device Identifier: 00887868269370
• UDI-Public: (01)00887868269370(17)270730(10)66860673
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: Lay User/Patient
• Device Catalogue Number: 110025990
• Device Lot Number: 66860673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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: 57 YR
• Patient Sex: Unknown