MAUDE Adverse Event Report: CONMED CORPORATION PARADIGM EZ SWITCH PORTAL PRESERVATION SYSTEM; ACCESSORIES, ARTHROSCOPIC

Catalog Number PEZS01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the pezs01 was being used during a hip arthroscopy, labral repair, femoral neck osteoplasty on (b)(6) 2020 when the seal dislodged and was pushed into the joint.The user was able to retrieve the component using a grasper.This caused a 1-minute delay in the procedure.The procedure was completed as planned using the same device as the procedure was at completion when the event occurred.There was no report of harm to the user or the patient.There was no medical intervention or hospitalization for the patient due to the event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation however the provided photographic evidence exhibits the reported event.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 961 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.003.Per the instructions for use, the user is advised the following: warnings: preoperative and operating procedure, including knowledge of surgical techniques and proper selection and placement of implants are important considerations in the successful utilization of these devices.Precautions: inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the user of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during insertion and use.Use care while passing sharp instrumentation to prevent damage to the device.Inspect instruments after use to ensure they have not been damaged.It is the responsibility of the surgeon to become familiar with the proper techniques for use.Maintain proper alignment during insertion.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PARADIGM EZ SWITCH PORTAL PRESERVATION SYSTEM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10419575
• MDR Text Key: 203302326
• Report Number: 1017294-2020-00366
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Catalogue Number: PEZS01
• Device Lot Number: 1047441
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/17/2020
• Patient Sequence Number: 1