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

Catalog Number	CM-9011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: (b)(6).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.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that during a procedure, the suture passer needle instrument was found to be fractured when removed from the packaging.Another device was used to complete the procedure.No patient impact or adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event, to date no further information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned suture passer needle confirmed that the needle is fractured.The weld is present on the needle and does not look like the weld fractured.It is noted that there are several damaged spots to the outer packaging of the needle.The needle width was confirmed to be conforming to the print specification.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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 at time of this report.

• Brand Name: QUATTRO SUTURE PASSER NEEDLE
• Common Device Name: NEEDLE, SUTURING, DISPOSABLE
• 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: 17850811
• Report Number: 3006108336-2023-00029
• Device Sequence Number: 19671168
• Product Code: GAB
• UDI-Device Identifier: 00887868270147
• UDI-Public: (01)00887868270147(17)250721(10)65512977
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 07/21/2025
• Device Catalogue Number: CM-9011
• Device Lot Number: 65512977
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose