MAUDE Adverse Event Report: CONMED CORPORATION MIMIX 3.5MM X 8CM , CUDA, 35 DEGREE, STEALTH; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number LE-35CUP

Device Problem Material Disintegration (1177)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

Please note that the patient's age was reported to be "20-something" year old.The reported complaint of black coating coming off of the device is confirmed.A visual examination of returned used item le-35cup confirmed the reported problem and found the back of the cuda inner tip discolored (black).The inner cuda found to rotate freely with no resistance needed.However, it is suspect excessive heat was applied to the inner cuda and discolored the tip coating.The examination was performed per design print and the blade is passivated per the specifications.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.A two-year lot history review was conducted and found no other similar complaints for this lot number and failure mode.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of 1 complaint, regarding 1 device, 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).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.In the ifu, the user is advised to always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.Do not apply excessive loading on the shaver blades or bur.Cutting performances 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.

Event Description

On behalf of the customer, the conmed representative reported issues with the le-35cup, mimix 3.5mm x 8cm, cuda, 35 degree, stealth, lot 1024527, experienced on (b)(6) 2019 in (b)(6).It was reported that during an ankle arthroscopy procedure on (b)(6) 2019, a le-35cup was used.It detached black stealth coating from the blade.The black coating sticks to both soft & hard tissue.It was reported that it looks like black fragment.It is indicated that there was no injury or impact to the patient at this time and the procedure was successfully completed with no delay.Additional clarification was obtained that indicates the patient was a "20-something" year old.It is noted the surgeon entered the ankle joint anteriorly using one le-35cup to uncover / dissect the loose bone fragment that was supposed to be removed.The le-35cup had been in use for approximately 4 minutes when some black fragments of the black coating detached from the stealth blade, sticking to both bone and soft tissue inside the joint.The doctor did push the blade into the tissue with a lot of great force.The shaver blade bent so he had to bend it back to its original curve.He also used oscillating mode on the shaver.The device was in contact with both hard and soft tissue when the substance was noted.The black substance looked more solid than liquid, but the doctor could not say for certain what it was or where on the device it was coming from as there was no visible damage on the device.The amount of the black substance was very little and was left in the patient.It was confirmed there is no impact to the patient at this time.This report is being raised on the basis of injury for the fragment/substance left in the patient.

• Brand Name: MIMIX 3.5MM X 8CM , CUDA, 35 DEGREE, STEALTH
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• Manufacturer Contact: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• MDR Report Key: 9209069
• MDR Text Key: 175757497
• Report Number: 1017294-2019-00138
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 20845854901707
• UDI-Public: (01)20845854901707(17)201110(10)1024527
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Catalogue Number: LE-35CUP
• Device Lot Number: 1024527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR