MAUDE Adverse Event Report: CAYENNE MEDICAL AFX FEMORAL IMPLANT 9X25MM; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is noted that the lot is unknown but two possible lots were given: d4 information for the possible lots: lot: 65319156 udi: (b)(4) mfg date:(b)(6) 2021 exp date: (b)(6) 2024 lot: 65615642 udi:(b)(4) mfg date: (b)(6)2022 exp date: (b)(6) 2025 the device was not reported to be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during surgery on the right side, the product fractured upon insertion.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was further reported, all broken parts were removed successfully from the patient immediately after the implant fractured.Another device was loaded and implanted successfully without any issues.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/corrected.Visual inspection of the returned device does not confirm the item and lot numbers as they are not etched on the device.The unibody and deployment screw are fractured.Part of the fractured deployment screw was not returned.The fractured pieces of the unibody also were not returned.The handle is missing the quick release pin, and the knob position is extended upon receipt.No other damage is noted.Medical records were not provided.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: AFX FEMORAL IMPLANT 9X25MM
• Common Device Name: FASTENER, FIXATION
• 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: 18520387
• Report Number: 3006108336-2024-00001
• Device Sequence Number: 7773774
• Product Code: MBI
• UDI-Device Identifier: 00887868380365
• UDI-Public: (01)00887868380365(17)250831(10)65615642
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K192428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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 Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CM-2509AFX
• Device Lot Number: 65615642
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female