MAUDE Adverse Event Report: CONMED CORPORATION 3.5MM STERLING CUDA 6 EA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number C9253

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2021

Event Type  Injury  

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 distributor reported on behalf of their customer that the c9253 device was being used during an unknown type of surgery on (b)(6) 2021 when it was originally reported "during the surgery, a metal piece was observed by a camera.This metal piece could come from the product.Please investigate the possibility if a metal piece could come from the product." upon review of the documentation, it was found that there was also a report that the "metal piece" was found in the device packaging prior to use.Further assessment information was requested from the reporter and to date we have not received any further information or clarification as to what occurred during the procedure in regard to the conmed device.Therefore, it is not known if the "metal piece" came from the conmed device, if the "metal piece" came into contact with the patient or if the "metal piece" was left in the patient.It is assumed that the "metal piece" remains in the patient since we have no further information.This report is being raised on the basis of injury due to unknown if "metal piece" remains in patient.

Manufacturer Narrative

Inspection of the returned bur item was unable to duplicate and/or confirm the reported problem as there were no physical defects noted on the unit.In addition, testing of the bur with a test hand piece found the unit performed as intended with no registering problems or discrepancies noted.Examination performed under 10 x magnifications and could not find any damage blade teeth.All blade teeth are intact and sharp.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 13 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).Per the instructions for use, the user is advised to not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 3.5MM STERLING CUDA 6 EA
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11588118
• MDR Text Key: 260435753
• Report Number: 1017294-2021-00164
• Device Sequence Number: 1
• Product Code: GFA
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C9253
• Device Lot Number: 1111485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 04/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other