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

Catalog Number DLH462

Device Problem Solder Joint Fracture (2324)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed's complaint system 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

On behalf of the customer, conmed (b)(4) received notice of reported issues with the 4.6mm double latch hip cannula, straight, item # dlh462, lot 079411, that (b)(6) hospital recently experienced on (b)(6) 2021.Information received indicates that during a hip arthroscopy, the dlh462 quick latch cannula came apart at the weld between the sheath and the connector.It is noted there was no impact or injury to the user or patient.The procedure was successfully completed with a 5minute delay by opening another instrument set to obtain and use an alternate dlh462.Additional information notes the cannula came apart at the weld when the surgeon inserted the cannula into the joint for the 1st time using the dlh460 obturator.At this time, he noticed the cannula was leaking, pulled the cannula out of the joint and the cannula came apart at the weld.The surgeon confirmed there was no damage to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported complaint of the dlh462 quick hatch came apart was confirmed based on photographic evidence of the returned device and device evaluation.The weld, based on the pictures, looks to be uniform and strong all the way around except for a small location where the shaft has a different texture.It was noted that there was a bit of corrosion at this location above the weld line which leads us to believe the failure propagated from this area and happened over time.The weld appears to be weaker at this location relative to the rest of the weld although it does shows evidence of complete penetration and looks like it would pass per laser welding specification.There was quite a bit of damage to the tip of the cannula as well as torsion witness marks at the cannula body which could have led to this failure.A review of the device history records (dhr) was requested from the manufacturer; however, has not been provided to date.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 for similar failure modes revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame 4,132 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.As this is a reusable device, the potential number of uses is not considered in this failure rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, 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 DOUBLE LATCH HIP CANNULA, STRAIGHT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 11863707
• MDR Text Key: 268247443
• Report Number: 1017294-2021-00268
• 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: 07/09/2021

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 Catalogue Number: DLH462
• Device Lot Number: 079411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/09/2021
• Patient Sequence Number: 1