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

Catalog Number	CM-9145SP
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in france.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
It was reported that, during placement of an anchor in the humeral head, the implant screw fractured when the anchor was impacted during the first stage of the procedure.The screw broke into four pieces, and when the ancillary device was removed, the implant support rods were observed to be bent at approximately a 90° angle.All fragments were recovered intra-operatively, and the event resulted in prolonged operating time.No known impact or consequence to the patient was reported.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/corrected updated: d4; d9; h2; h3; h4 corrected: d4 (lot info) 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
No further event information available at the time of this report.
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: h2; h3; h6.Complaint sample was evaluated, and the reported event was confirmed.The returned device shows signs of use as well as wear and tear.Both prongs on the tip of the inserter are bent to one side and the metal tipped end of the anchor has fractured and not all of the anchor pieces have been returned.Measured the diameter of the remaining portion of the anchor to confirm it is conforming to print specifications as well verified that the inserter handle is black and the knotless knob is purple.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: QUATTRO LINK ANCHOR 4.5MM SP
• 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: 23680931
• Report Number: 3006108336-2025-00038
• Device Sequence Number: 9754001
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)291211(10)67025306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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-9145SP
• Device Lot Number: 67025306
• 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: 02/23/2026; 04/16/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/24/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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