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

Catalog Number 35VTX-SJ-ZZ

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2020

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 sales representative reported on behalf of the customer that the 35vtx-sj-zz device was being used during an ankle arthroscopy on (b)(6) 2020 when the bur head detached from the device and fell into the patient.Further assessment questioning found that the component was not found or retrieved.The procedure was not completed as planned.There was no report of injury, medical intervention or hospitalization for the patient.This report is being raised on the basis of injury due to detached component being reported as lost in the patient.

Manufacturer Narrative

Evaluation of the returned used device found the inner blade tip broken off.Examination performed per a30-438-437 rev aa.The broken piece, however, was not returned for evaluation.Manufacturing has been informed of this issue and have contacted the vendor regarding this issue.Correspondence from the vendor indicated that the lot and sublot used to produce the inner tube assembly were manufactured following all standard operations and process parameters with no deviations or product nonconformances.Quality and manufacturing engineering review of the finished good lot found no nonconformances related to the manufacture of the device and only 1 complaint for this issue, the subject complaint.Additionally, evaluation of the device by a manufacturing process specialist, found heavy galling on the inside of the hood as well as some small gouges where it appears that the cutting edge hit the hood.Light galling on the inner tube was found approximately halfway up the shaft.Based on this investigation, the device was used in rough manner which caused the failure.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 14 complaints, regarding 15 devices, for this device family and failure mode.During this same time frame 300,534 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 0.00005.Per the instructions for use, the user is advised the following: precautions: -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.-do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using the shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 3.5MM STERLING VORTEX
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10642966
• MDR Text Key: 210224212
• Report Number: 1017294-2020-00432
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 35VTX-SJ-ZZ
• Device Lot Number: 1067918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 10/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other