MAUDE Adverse Event Report: CONMED CORPORATION 2.0MM STERLING FULL RADIUS RESECTOR; ARTHROSCOPIC BLADE/BUR

Catalog Number	C9940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.Evaluation was performed and confirmed that the inner tube was broken off at the tip, not the weld location.Broken blade tip was returned for evaluation.Outer tube shows no signs of misuse.Critical dimensions and found no issue.This is a technique-dependent device and the most likely cause of this failure is user-related.Excessive force, lateral/side loading, and/or stalling of the device was used that caused the bur inner tube to break.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.(b)(4).Per the instructions for use, the user is advised the following: 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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the c9940, 2.0mm sterling bur, during the surgery, tip of the inner shaft of this product was broken.The tip was retrieved.Pictures were provided.There was no patient injury or delay of surgery reported.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 2.0MM STERLING FULL RADIUS RESECTOR
• Common Device Name: ARTHROSCOPIC BLADE/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8457222
• Report Number: 1017294-2019-00038
• Device Sequence Number: 354659
• Product Code: GFA
• UDI-Device Identifier: 10845854017739
• UDI-Public: (01)10845854017739(17)230813(10)953183
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 08/13/2023
• Device Catalogue Number: C9940
• Device Lot Number: 953183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1