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

Catalog Number	CM-9255X3
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d9; h2; h3; h6.Reported event was able to be confirmed due to device returned.It was confirmed that the suture thread was fractured and not the anchor.Visual examination of the returned device identified that the suture was returned with a knot near end of the suture where the end is frayed.Confirmed that there are 3 bundles of multifilament tracer included in the suture.Measured the suture length with a ruler which measures under 19".Also measured the diameter of the suture with micrometers and the measurement was within the specs listed in the attached raw material spec.No additional part of the device was returned product was returned or additional pictures provided; further 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.

• 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: 50115038
• Report Number: 3006108336-2026-00019
• Device Sequence Number: 20160184
• Product Code: MBI
• UDI-Device Identifier: 00887868270284
• UDI-Public: (01)00887868270284(17)310324(10)67806008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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-9255X3
• Device Lot Number: 67806008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2026
• 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