MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER GT

Model Number N/A

Device Problems Device Damaged Prior to Use (2284); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that suture passer malfunctioned during surgery, damaging two suture passer needles and cutting the sutures.45 minutes surgical delay was reported.No other patient harm was reported.

Manufacturer Narrative

Customer has not returned the device for investigation despite three attempts.Complaint was not confirmed, and the root cause of this event cannot be determined.Dhr and complaint history for lot number were unable to reviewed since the lot number was not provided.Complaint history was reviewed using catalog number and reported complaint categories, and it was determined no capa is required.Dfmea was investigated for the failure mode, and it is captured.Cayenne will continue to monitor for future events.H3 other text : device not returned.

Event Description

It was reported that suture passer malfunctioned during surgery, damaging two suture passer needles and cutting the sutures.45 minutes surgical delay was reported.No other patient harm was reported.

• Brand Name: QUATTRO SUTURE PASSER GT
• Type of Device: SUTURE PASSER
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 9886169
• MDR Text Key: 186565273
• Report Number: 3006108336-2020-00006
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9010GT
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention