MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM STERLING, LIGHTNING, 6 EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	H9133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned, used device found the bur detached from the inner hub due to oversized hub.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 has been one other complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 34 complaints, regarding 42 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the handpiece instructions for use, the user is advised the following: - prior to each use, perform the following: - ensure all accessories are correctly and completely attached.- perform the required preoperative functional tests for the equipment and accessories.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that h9133, 4.5mm sterling, lightning, 6 ea, device came apart during a subacromial decompression procedure on (b)(6) 2018.The event did not cause any delay or cancellation of the procedure.No component of the device came into contact with the patient.There was no report of injury to patient or user.Another h9133 device was used to complete the procedure and the procedure was completed successfully.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM STERLING, LIGHTNING, 6 EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7777689
• Report Number: 1017294-2018-00127
• Device Sequence Number: 19162326
• Product Code: GFF
• UDI-Device Identifier: 10845854029671
• UDI-Public: (01)10845854029671(17)220813(10)859053
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/13/2018

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: 08/13/2022
• Device Catalogue Number: H9133
• Device Lot Number: 859053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1