MAUDE Adverse Event Report: CONMED CORPORATION 4.2MM STERLING CUDA, QTY 6; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	C9254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On behalf of their customer, conmed (b)(4) reported issues with the 4.2mm sterling cuda # c9254, lot 1154878, recently experienced by (b)(6) on (b)(6) 2021.Information received indicates shaver broke during use in an achilles procedure.It is noted the procedure was successfully completed by using another 4.2 cuda with no impact or injury to the patient.To date, additional information has been requested, but per the reporter, at this time there is no other information available.This incident will be reported on the basis of malfunction with potential for injury upon reoccurrence because clarification of the term "broke" and if there was patient contact can not be obtained.
Additional Manufacturer Narrative
The reported event of ¿blade broke during use¿ is inconclusive.The device in question, used in the procedure, is not available for evaluation by conmed.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, and root cause cannot be identified.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar events reported for this lot number.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also per the ifu the user is advised to 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.

• Brand Name: 4.2MM STERLING CUDA, QTY 6
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12387699
• Report Number: 1017294-2021-00320
• Device Sequence Number: 11943040
• Product Code: GFA
• UDI-Device Identifier: 10845854017531
• UDI-Public: (01)10845854017531(17)260315(10)1154878
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 03/15/2026
• Device Model Number: C9254
• Device Catalogue Number: C9254
• Device Lot Number: 1154878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1