MAUDE Adverse Event Report: CONMED CORPORATION 4.6MM DOUBLELATCH HIP CANNULA STRAIGHT; ACCESSORIES, ARTHROSCOPIC

Catalog Number DLH462

Device Problem Material Fragmentation (1261)

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

Event Date 03/04/2021

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 dlh462 device was being used during a cam and pincer hip artro on (b)(6) 2021 when it was reported "the 4.6mm doublelatch hip cannula straight broke during the operation and the tube disappeared into the soft tissue / muscles and joints.The doctor had to try to fish it out with the help of various instruments.And this took about 35min".There was no report of injury, medical intervention, or hospitalization to the patient.The procedure was completed using an alternate same device with a 35-minute delay.Further assessment questioning confirmed that all pieces were removed from the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

During inspection of the returned dlh462 hip cannula, it was noted the laser weld joining the hub and cannula body had failed in a uniform, annular crack.The two components could be re-mated and observed a tight slip fit.Under magnification, no evidence was found to determine if the failure was caused by excessive torque or bending.The distal end of the device shows signs of damage in the form of scratches and deformed material resulting in sharp edges and burs not consistent with the production process.These marks were identified on the exterior diameter, no marks observed on in interior diameter.A device history record review cannot be conducted as a valid lot number was not provided.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.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 3,993 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 0.0005.Per the instructions for use, the user is advised that before each assembly and after each sterilization, carefully inspect all parts of the system for damage or discoloration.Do not use instruments if damaged or discolored.All parts should be assembled and disassembled before use to ensure proper fit.Do not use excessive force when inserting arthroscope into the bridge.Forced insertion could damage the arthroscope or bridge system.Do not use the cannula as a lever or pry.Damage may result.Do not use with any other doublelatch component, except the dl1008, dl1009 and dl1010.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 4.6MM DOUBLELATCH HIP CANNULA STRAIGHT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11569801
• MDR Text Key: 242736483
• Report Number: 1017294-2021-00159
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DLH462
• Device Lot Number: 097311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Date Manufacturer Received: 05/25/2021
• Patient Sequence Number: 1