MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK SP KNOTLESS ANCHOR 4.5MM PEEK ANCHOR TITANIUM TIP; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	CM-9145SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: (b)(6).H3: 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 after the surgeon had implanted the anchor, they removed the anchor and found that the implant fractured at the cleat.There was no report of harm or foreign body retained by the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d9, g3, g6, h1, h2, h3, h6, h11 reported event was confirmed by review of pictures.Visual examination of the provided photographs identified that the anchor is fractured near the eyelet.Anchor remains in one piece as fracture is on one side of the eyelet.Device inserter was returned however, anchor was not returned with the inserter, further visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: QUATTRO LINK SP KNOTLESS ANCHOR 4.5MM PEEK ANCHOR TITANIUM TIP
• Common Device Name: FASTNER, 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: 19972919
• Report Number: 3006108336-2024-00027
• Device Sequence Number: 7115397
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)280330(10)65956903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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-9145SP
• Device Lot Number: 65956903
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 01/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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: Prefer Not To Disclose