MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 5.5MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CM-9155
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in india.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
During intraoperative setup and implantation, the anchor disengaged/pulled out while the implant was being deployed.Provided photos identified that the anchor is also fractured.No additional details were provided regarding the specific procedure, intraoperative findings, corrective actions taken, or whether a replacement device was used.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: d4; d5; d9; h2; h3; h4; h6.Complaint sample was evaluated, and the reported event was confirmed.The anchor has fractured into two pieces, and the tip of the anchor has been flattened as shown in the photos.The quattro link anchor 5.5mm returned shows signs of use as well as wear and tear.The device and anchor were returned.The snare loop assembly was not returned.The prongs on the tip of the device are bent and touching.The inserter handle is conforming to print specifications with a purple knob and black handle.Dimensional analysis of the anchor was not performed due to damage.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: QUATTRO LINK ANCHOR 5.5MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23681258
• Report Number: 3006108336-2025-00039
• Device Sequence Number: 9699524
• Product Code: MBI
• UDI-Device Identifier: 00887868270222
• UDI-Public: (01)00887868270222(17)291015(10)66969066
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 Catalogue Number: CM-9155
• Device Lot Number: 66969066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Male