MAUDE Adverse Event Report: CAYENNE MEDICAL CROSSFIX MENISCAL SYS STRAIGHT

Model Number N/A

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 01/15/2020

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 patient underwent a meniscectomy due to a device malfunction.No other patient harm or surgical delay was reported.No other device was used to complete the surgery.

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was not confirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 h3 other text : device not returned.

Event Description

It was reported that patient underwent a meniscectomy due to a device malfunction.No other patient harm or surgical delay was reported.No other device was used to complete the surgery.

• Brand Name: CROSSFIX MENISCAL SYS STRAIGHT
• Type of Device: CROSSFIX
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 9700198
• MDR Text Key: 178796611
• Report Number: 3006108336-2020-00002
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: K121413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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 Expiration Date: 04/03/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-8001
• Device Lot Number: 65952-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability