MAUDE Adverse Event Report: Cayenne Medical QUATTRO X3 ANCHOR 5.5MM; Fastener, Fixation, Nondegradable, Soft Tissue

Catalog Number	CM-9255X3
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• Brand Name: QUATTRO X3 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 ; +1(574)526-0384
• MDR Report Key: 50519580
• Report Number: 3006108336-2026-00022
• Device Sequence Number: 9375213
• Product Code: MBI
• UDI-Device Identifier: 00887868270284
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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
• Device Catalogue Number: CM-9255X3
• Device Lot Number: 67025063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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 Sex: Unknown