MAUDE Adverse Event Report: CAYENNE MEDICAL CROSSFIX MENISCAL SYS CURVED; SUTURE, NONABSORBABLE

Model Number	N/A
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3006108336-2021-00019.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 an initial procedure, the crossfix curved meniscal suture does not thread on the needle.Another implant is tried and the exact same thing happens.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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 returned product identified the products were returned with minimal signs of use and the sutures separated from the devices.The sheaths for both devices extend and retract over the inserter tips smoothly.The trigger mechanism deploys the passer needle on both devices.The inserter tips are bent out of alignment and the passer needles strikes and pushes the passer needles further apart.The passer needle can't slide smoothly into the transfer slot.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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: CROSSFIX MENISCAL SYS CURVED
• Common Device Name: SUTURE, NONABSORBABLE
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• MDR Report Key: 11740279
• Report Number: 3006108336-2021-00018
• Device Sequence Number: 3148964
• Product Code: GAT
• UDI-Device Identifier: M543CM8002
• UDI-Public: M543CM8002
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2021

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: 04/02/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-8002
• Device Lot Number: 65737-2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 07/27/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/26/2021; 08/16/2021
• 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