MAUDE Adverse Event Report: CONMED CORPORATION 4.0MM STERLINF OVAL BUR HIGH SPEED; ARTHROSCOPIC SHAVER/BUR

Catalog Number	H9101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence was provided that verifies that the bur tip detached from the shaft.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.There have been no other similar complaints for this lot of product.A two-year review of complaint history revealed there has been a total of 31 complaints, regarding 32 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 instruction for use, the user is advised the following; do not use equipment if upon receipt, package is opened, damaged, or shows signs of tampering.Continually check for overheating, if overheating is sensed immediately discontinue use.Do not use burs for plunge cutting.Injury or damage could occur.Do not use shaver bur if they show any signs of damage.Inspect for bent, dull, or damaged blades and burs before each use.Do not apply excessive loading/force on the shaver blade or bur.Direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices, shaver blade or bur should be examined for damage and replaced if necessary.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported the h9101 bur, broke off in the patient's bone during a shoulder arthroscopy procedure.The bur was being used through a cannula to resect bone when it broke off.The fragment was retrieved using a kelly clamp and grasper.There was no patient injury.There was no reported delay and the procedure was completed as planned.No other bur was needed to finish the surgery.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.0MM STERLINF OVAL BUR HIGH SPEED
• Common Device Name: ARTHROSCOPIC SHAVER/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8176148
• Report Number: 1017294-2018-00185
• Device Sequence Number: 13998002
• Product Code: GFF
• UDI-Device Identifier: 10845854017210
• UDI-Public: (01)10845854017210(17)230312(10)910932
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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: 03/12/2023
• Device Catalogue Number: H9101
• Device Lot Number: 910932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR