MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 4.5MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	CM-9145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: cm-9145, quattro link anchor 4.5mm; lot#: 65647694.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital.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 of the product was fractured.There was no report of a foreign body retained or harm to the patient.Attempt has been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h2; h3; h6.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: QUATTRO LINK ANCHOR 4.5MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• 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: 22510247
• Report Number: 3006108336-2025-00024
• Device Sequence Number: 8652248
• Product Code: MBI
• UDI-Device Identifier: 00887868270192
• UDI-Public: (01)00887868270192(17)270317(10)65415428
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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-9145
• Device Lot Number: 65415428
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown