MAUDE Adverse Event Report: CONMED LARGO 5.5MM (I.D.) X 70MM SHOULDER CANN SET WITHOUT FENES; ACCESSORIES,ARTHROSCOPIC

Catalog Number 9718

Device Problem Detachment of Device or Device Component (2907)

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

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 9718, 5.5mm (i.D.) x 70mm shoulder cann set without fenes, was being used during an unknown procedure on an unknown date when it was reported.¿ the dam is able to be pushed out of the cannula and into the joint space (he is able to retrieve it when this occurs).¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device fell into the patient and was retrieved.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned and no photographic evidence was provided therefore, a device malfunction cannot be verified.The device history record was not reviewed because the lot number is not known.The lot history review was not conducted because the lot number is not known.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 (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 9718, 5.5mm (i.D.) x 70mm shoulder cann set without fenes, was being used during an unknown procedure on an unknown date when it was reported, ¿¿the dam is able to be pushed out of the cannula and into the joint space (he is able to retrieve it when this occurs).¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device fell into the patient and was retrieved.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.5MM (I.D.) X 70MM SHOULDER CANN SET WITHOUT FENES
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18884540
• MDR Text Key: 337425086
• Report Number: 1017294-2024-00026
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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: 9718
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic