MAUDE Adverse Event Report: CONMED CORPORATION 4.0MM STERLING OVAL BUR; ARTHROSCOPIC SHAVER/BUR

Catalog Number	H9101
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.Examination found bur tip was detached from inner tube.Blade missed laser welding process.The bur tip was not welded to the inner tube.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 8 complaints regarding (b)(4) 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; always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported the h9101, shaver bur, fell off in a shoulder joint during and arthroscopic shoulder procedure on (b)(6) 2019.The bur fragment was safely removed from the patient's joint.There were no issues noticed with the bur prior to use.The procedure was completed successfully with another of the same type of bur and lot number.There were no reported patient or user injuries and no reported delay.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.0MM STERLING OVAL BUR
• Common Device Name: ARTHROSCOPIC SHAVER/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8370741
• Report Number: 1017294-2019-00018
• Device Sequence Number: 2024558
• Product Code: GFF
• UDI-Device Identifier: 10845854017210
• UDI-Public: (01)10845854017210(17)230307(10)910260
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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: 03/07/2023
• Device Catalogue Number: H9101
• Device Lot Number: 910260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1