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.

• 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

• 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

• 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 Treatment Data

Date Received: 07/14/2021 Patient Sequence Number: 1

Treatment

912029 JGRKNT 2.9MM #2 SNGL NGLE LOT#P12896; CM-9011 QUATTRO SUTURE PASSER NEEDLE LOT#75957-1