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

Catalog Number	CM-9145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a soft tissue fixation procedure, the anchor tip fractured when inserted into the bone.All parts of the anchor were successfully removed from the joint.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.The case was completed without any adverse outcomes to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in germany.The customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event is unconfirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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 KNOTLESS ANCHOR 4.5MM
• 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 ; 5745260384
• MDR Report Key: 21237258
• Report Number: 3006108336-2025-00004
• Device Sequence Number: 8075560
• Product Code: MBI
• UDI-Device Identifier: 00887868270192
• UDI-Public: (01)00887868270192(17)290625(10)66834034
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/29/2025

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: 66834034
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 01/26/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 92 KG