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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).It is unknown if the device will be returned for analysis at this time; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the quattro suture passer needle broke during the surgery.There was a 2 minute delay in the procedure to prepare new suture passer with different needle.The procedure was successfully finished with another needle.There was no impact on patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the product was returned with significant signs of use in the form of nicks to the passer shaft and the ribbon fractured.The ribbon is fractured just before the weld on the tip of the device but the weld is intact.There is a slight bend in the larger section of the fractured ribbon and an upward bend to the fragment that is still welded in place on the passer tip.There are a few nicks to the shaft of the device but no other damage of note.Review of the device history records identified no deviations or anomalies during manufacturing.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 SUTURE PASSER NEEDLE
• Type of Device: SUTURING NEEDLE, SINGLE-USE
• 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: 12165813
• MDR Text Key: 261468839
• Report Number: 3006108336-2021-00029
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: N/A
• Device Catalogue Number: CM-9011
• Device Lot Number: 69519-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 912029 JGRKNT 2.9MM #2 SNGL NGLE LOT#P12896; CM-9011 QUATTRO SUTURE PASSER NEEDLE LOT#75957-1; 912029 JGRKNT 2.9MM #2 SNGL NGLE LOT#P12896; CM-9011 QUATTRO SUTURE PASSER NEEDLE LOT#75957-1