MAUDE Adverse Event Report: CONMED CORPORATION 3.5MM STERLING SPERICAL BUR; ARTHROSCOPIC SHAVER/BUR

Model Number	H9110
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
Complaint is confirmed.Evaluation was performed and confirmed that the inner tube was broken off at the tip.The broken blade tip was returned for evaluation.This is a technique dependent device and the most likely cause of this failure is user-related.Suspected excessive force, lateral/side loading and / or stalling of the device was used that caused the bur inner tube to break off.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 29 complaints regarding 30 devices 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; 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 bur as a lever can cause damage to the device including permanent deformation, shredding 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 zimmer biomet representative reported that the h9110, shaver bur's inner shaft broke during an ankle surgery on (b)(6) 2018.The bur loaded with no issues into the handpiece, the bur broke while shaving an osteophyte.There were no fragments in the patient, so nothing had to be retrieved.There was no patient injury and no surgical delay.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 3.5MM STERLING SPERICAL BUR
• Common Device Name: ARTHROSCOPIC SHAVER/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8345540
• Report Number: 1017294-2019-00011
• Device Sequence Number: 11220894
• Product Code: GFF
• UDI-Device Identifier: 10845854012802
• UDI-Public: (01)10845854012802(17)230730(10)946448
• 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): 02/15/2019

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: 07/30/2023
• Device Model Number: H9110
• Device Catalogue Number: H9110
• Device Lot Number: 946448
• 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: 01/27/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1