MAUDE Adverse Event Report: CONMED LARGO POWERPRO ELECTRIC II MODULAR HANDPIECE; ARTHROSCOPE

Catalog Number PRO6100

Device Problem Self-Activation or Keying (1557)

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

Event Date 05/22/2023

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 distributor reported on behalf of their customer that the pro6100, powerpro electric ii modular handpiece, was being used during a knee prosthesis procedure on (b)(6) 2023 when it was reported ¿when connecting the electric cable, the handpiece starts without pressing the start button.The engine actuation button and safety lever/direction selection are non-functional.The handpiece doesn't work properly, and it can't be controlled inside the sterile field.¿.It was reported that the procedure was completed without delay and there was no report of injury, medical intervention, or hospitalization for the patient or user.The current status of the patient and user were reported as "both are ok.".This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Event Description

The distributor reported on behalf of their customer that the pro6100, powerpro electric ii modular handpiece, was being used during a knee prosthesis procedure on (b)(6) 23 when it was reported ¿when connecting the electric cable, the handpiece starts without pressing the start button.The engine actuation button and safety lever/direction selection are non-functional.The handpiece doesn't work properly, and it can't be controlled inside the sterile field.¿.It was reported that the procedure was completed without delay and there was no report of injury, medical intervention, or hospitalization for the patient or user.The current status of the patient and user were reported as "both are ok.".This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.The service history was reviewed, and no data was found.A device history review was not conducted as the device has been in the field more than 12 months.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame 736 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 to handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.The user is also advised to perform the required preoperative functional tests for the equipment and accessories prior to each use.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: POWERPRO ELECTRIC II MODULAR HANDPIECE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberrry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17131956
• MDR Text Key: 317450717
• Report Number: 1017294-2023-00053
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K981269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO6100
• Device Lot Number: LAA08898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic