MAUDE Adverse Event Report: CONMED CORPORATION 2.0MM STERLING CUDA MICROBLADE; ATHROSCOPIC SHAVER BLADE

Catalog Number	C9950
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.Evaluation confirmed the reported problem and found the inner tube broken off at the tip.Broken blade was not returned for the evaluation and is approximately 0.112 inches.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 1 complaint regarding 1 device for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; not to 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 in 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
The customer reported the c9950, 2.0mm sterling cuda shaver blade, broke during an arthroscopic hand procedure on (b)(6) 2018.The tip broke off during use and the bur tip was retrieved.There was no patient injury and no reported delay.The surgery was completed as planned.This report is being raised on the basis of device malfunction with potential for injury upon reoccurrence.

• Brand Name: 2.0MM STERLING CUDA MICROBLADE
• Common Device Name: ATHROSCOPIC SHAVER BLADE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8338896
• Report Number: 1017294-2019-00015
• Device Sequence Number: 16701537
• Product Code: GFA
• UDI-Device Identifier: 10845854017548
• UDI-Public: (01)10845854017548(17)230611(10)938012
• 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,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: 06/11/2023
• Device Catalogue Number: C9950
• Device Lot Number: 938012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1