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

Catalog Number PRO6100

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation was performed per spm31208000-1g and found that unit runs on its own/intermittent.Unit is wet and corroded inside.Housing is damaged.Motor and controller failed.Suspect root cause of the reported issue is mode switch failure, as a faulty mode switch can cause unanticipated activation of the handpiece.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.The service history was reviewed, and the switch index button has previously been replaced twice on this device.(b)(4).Per the instructions for use, the user is advised the following: warnings: always place the handpiece in the "safe" position when not in use and prior to repositioning the rotating head on the oscillatory saw, rotating the collet on the reciprocating saw, or connecting or removing attachments and accessories.Precautions: handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperative functional tests for the equipment and accessories.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that pro6100 device "runs on its own".This was reported to have happened during an elbow distal biceps tendon repair and/or reconstruction on (b)(6) 2019.This event caused a 10-minute delay in the procedure to change out equipment.The patient is reported to be "healing fine".There was no reported injury to the user or the patient.There was no medical intervention or hospitalization required.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: POWERPRO ELECTRIC II MODULAR HANDPIECE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 8641432
• MDR Text Key: 146379184
• Report Number: 1017294-2019-00057
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO6100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1