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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was undergoing right shoulder surgery.Surgeon was using a quattro link sp knotless anchor and the tip of the device broke off in patient.Surgeon was able to retrieve the broken pieces of the device and the surgery was completed.No harm to patient was noted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: complaint was notified to us by mw5155580, mdr report key: (b)(4).Customer has indicated that the product can be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b1; b2; b3; b5; b7, h1; h2; h3.The investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient underwent a right rotator cuff repair.While placing the anchor, the tip fractured off and went into the joint.The titanium tip and most of the pmma was extracted but approximately a 1mm piece was left in the synovium, deep in the pouch.The procedure was completed without further complications.Attempts have been made and additional information on the reported event is unavailable at this time.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: while placing the anchor, the tip broke off and went into the joint.The titanium tip and most of the pmma was extracted but approximately a 1mm piece was left in the synovium, deep in the pouch.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 LINK SP KNOTLESS ANCHOR 4.5 PEEK ANCHOR
• 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: 19762093
• Report Number: 3006108336-2024-00025
• Device Sequence Number: 20983551
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)281019(10)66267346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9145SP
• Device Lot Number: 66267346
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 09/17/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 73 KG