MAUDE Adverse Event Report: CONMED CORPORATION POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO6047

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/12/2020

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 customer reported that the device, (b)(4), was being used during surgery on (b)(6) 2020 when the device "came apart".Upon further assessment, all pieces were retrieved, and there was no report of injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Corrected data: g4 the combination product was mistakenly checked.Evaluation of the unit per ip-000-387 found the unit failed testing due to a negative torque test, lack of loctite and the bearings were worn and rough.Additionally, the pm is overdue.The device was cleaned, parts were replaced, the device repaired, and the pm performed; the device was final tested and met all specifications.A device history review was not conducted as the device has been in the field more than 12 months.The service history was reviewed, and no previous service data was found.At the time of the complaint, the device was 54 months of age.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding (b)(4) 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 0.0007.Per the instructions for use, the user is advised the following: ifu w55-000-852 advises the user that conmed linvatec recommends that all powerpro attachments be returned for preventive maintenance every 24 months.The ifu also advises the user that failure to follow the maintenance schedule could result in reduced instrument performance or overheating of the handpiece.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10758080
• MDR Text Key: 213871315
• Report Number: 1017294-2020-00467
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PRO6047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1