MAUDE Adverse Event Report: CONMED CORPORATION 5.0MM STERLING OVAL BUR; ARTHROSCOPIC BUR/SHAVER

Model Number	H9103RH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned, used item h9103rh, bur, found the inner tube hub broken off in the middle.Examination could not find any discrepancies with inner tube critical dimensions.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 7 complaints regarding 9 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 apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force 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.
Event or Problem Description
The customer reported the h9103rh, shaver bur "broke at hub during surgery on (b)(6) 2018, all parts removed.No injury" photos were provided to show the broken bur.Additional information received stated there was no delay of surgery, no issues with inserting the bur into the shaver handpiece and another of the same bur was used to complete the surgery.The bur broke in the middle of surgery and it was being used through the cannula, not the incision site.There were no other instruments in use with the bur and the staff was familiar with using the product.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.0MM STERLING OVAL BUR
• Common Device Name: ARTHROSCOPIC BUR/SHAVER
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8266833
• Report Number: 1017294-2019-00002
• Device Sequence Number: 16653003
• Product Code: GFF
• UDI-Device Identifier: 10845854018590
• UDI-Public: (01)10845854018590(17)221105(10)876948
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 11/05/2022
• Device Model Number: H9103RH
• Device Catalogue Number: H9103RH
• Device Lot Number: 876948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1