MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/25/2020

Event Type  malfunction  

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 report will be submitted.

Event Description

It was reported that two needles fractured during surgery causing surgical delay of 45 minutes.No other patient harm was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b1; b4; b5; d4; e1; e2; e3; g3; g4; g7; h1; h2; h3; h6.B1: product problem - surgical delay is not considered a serious event; therefore, only product problem is checked for this field.H1: malfunction - surgical delay is not considered a serious event; therefore, only malfunction is checked for this field.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: ncr 4419.A definitive root cause cannot 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 Description

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

• Brand Name: QUATTRO SUTURE PASSER NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 10326858
• MDR Text Key: 200433147
• Report Number: 3006108336-2020-00020
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 01/27/2021

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 Expiration Date: 10/25/2021
• Device Model Number: N/A
• Device Catalogue Number: CM-9011
• Device Lot Number: 69071-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention