MAUDE Adverse Event Report: CONMED UTICA ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number C08-65

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and 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 device, c08-65, was being used on (b)(6) 2021 during a rotator cuff repair procedure and the ¿surgeon was inserting cannula into shoulder and 1 cannula partial distal flange snapped off.Opened second cannula and whole distal tip and flange broke off.All part of cannula removed safely from patient.¿ there was a two minute delay and the procedure was completed with an arthrex passport cannula.The arthrex passport cannula will be listed as a concomitant device.There was no patient injury or impact to the 75 year old, male patient weighing 98kg and no further intervention required.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the device, c08-65, was being used on 8jul21 during a rotator cuff repair procedure and the ¿surgeon was inserting cannula into shoulder and 1 cannula partial distal flange snapped off.Opened second cannula and whole distal tip and flange broke off.All part of cannula removed safely from patient.¿ there was a two minute delay and the procedure was completed with an arthrex passport cannula.The arthrex passport cannula will be listed as a concomitant device.There was no patient injury or impact to the 75 year old, male patient weighing 98kg and no further intervention required.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event ¿cannula partial distal flange snapped off¿ was confirmed based on photographic evidence and device evaluation.Visual examination of the returned used product found both cannulas broken off device at the tip.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 two complaints, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) 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 0.0002.Per the instructions for use, the user is advised the following: inspect cannula prior to use to ensure they are in good physical condition.To avoid damaging seals and excessive leakage, do not use with devices larger than the specified cannula diameter.Use carefully to ensure the cannula is not bent or collapsed when inserting devices.To avoid damage during use, do not use excessive force on cannula.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• MDR Report Key: 12385541
• MDR Text Key: 271932088
• Report Number: 1320894-2021-00329
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00653405001631
• UDI-Public: (01)00653405001631(17)260404(10)202104051
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C08-65
• Device Lot Number: 202104051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTHREX PASSPORT CANNULA; ARTHREX PASSPORT CANNULA
• Patient Age: 75 YR
• Patient Weight: 98