MAUDE Adverse Event Report: CONMED CORPORATION MICROFREE OSCILLATING SAW; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO8300SB

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received.At time of filing, although expected, the reported device has not been 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

On behalf of their customer, the conmed sales representative reported an issue with the pro8300sb, microfree oscillating saw, serial #: (b)(4), that occurred on (b)(6) 2019 at (b)(6) hospital.It was reported only that "the tip broke off inside patient, piece was retrieved, no injury to patient".To date, although multiple attempts have been made to gather additional information and clarification, no further information has been provided.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence (fragment fell into the patient but was retrieved).

Manufacturer Narrative

The reported complaint is confirmed.An evaluation by conmed r&d found that the upper portion of the output shaft fractured through most of the cap.Large section of cap and pins were lost; one remaining pin extended from upper surface.There is minor evidence of rust on cap and inner surfaces of holes.Also, light rust stains on laser etching lettering close to power unit connection were present.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 were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.The service history was reviewed, and no prior data was found.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of (b)(4) 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 (b)(4).Please note however, because 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.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.Per the ifu, the user is also advised to not use burs for plunge cutting.Injury or damage may occur.Handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.Use only associated conmed approved equipment and accessories.Using unapproved accessories may result in improper operation and may result in non-compliance to medical standards.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROFREE OSCILLATING SAW
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 9328084
• MDR Text Key: 202508312
• Report Number: 1017294-2019-00150
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO8300SB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1