MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE; NEEDLE, SUTURING

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source : foreign : (b)(6).Customer has not indicated whether the product will be 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 there was needle breakage during use.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.D10 : part cm-9011 quattro suture passer needle lot 79862-1.Visual examination of the returned product identified that the product was returned with significant signs of use with the ribbon tip bent and fractured.The shaft and plastic tab show no signs of damage or deformity.The ribbon tip is in place and the weld holding the ribbon in place is intact.The tip of the ribbon is bent severely and nearly folded in half.The prongs have fractured off, leaving a straight edge.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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
Another device was used to complete the procedure, no product fell in patient.No further event information available at the time of this report.

• Brand Name: QUATTRO SUTURE PASSER NEEDLE
• Common Device Name: NEEDLE, SUTURING
• 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: shima hashemian ; 16597 n 92nd street; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 12680707
• Report Number: 3006108336-2021-00046
• Device Sequence Number: 3991297
• Product Code: GAB
• UDI-Device Identifier: 00887868270147
• UDI-Public: (01)00887868270147(17)230902(10)77372-1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 09/02/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-9011
• Device Lot Number: 77372-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown