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

Catalog Number	C9253
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned used device confirms the reported problem and found the inner tube bent and broken off at the inner hub assembly.The outer tube was not returned for evaluation.Suspect excessive force used on the device and it was operated under the high speed/torque for extended period of time.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.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 4 complaints, regarding 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 handpiece instructions for use, the user is advised the following: precautions: direct contact of the rotating cutting edge of the shaver blades or burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.Do 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.
Event or Problem Description
This distributor reported on behalf of their customer that the c9253, 3.5 mm sterling cuda 6 ea, device "fractured at the proximal side" during a unknown type of surgery on (b)(6) 2018.The event caused a 0-15-minute delay in the procedure.The procedure was completed successfully with no report of injury to the user or patient.There were no fragments or components lost in the surgical site; therefore, there was nothing to retrieve.There was no report of extended hospital stay or medical intervention required for the patient.No other requested information was available per the reporter.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Initially it was reported that the outer tube of the device was not returned for evaluation.It was found that the outer tube was returned and the inner tube was concealed inside the outer tube.Upon re-evaluation it was determined that both the outer tube and inner tube were bent.As stated previously, both tubes were found to be broken off of the assembly.

• Brand Name: 3.5MM STERLING CUDA 6 EA
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7843771
• Report Number: 1017294-2018-00135
• Device Sequence Number: 16461679
• Product Code: GFA
• UDI-Device Identifier: 10845854012543
• UDI-Public: (01)10845854012543(17)221207(10)886845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2022
• Device Catalogue Number: C9253
• Device Lot Number: 886845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1