MAUDE Adverse Event Report: CONMED LARGO 4.0MM OVAL BUR, EXTENDED LENGTH, (19CM); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	EL9101
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, el9101, 4.0mm oval bur, extended length, (19cm), was being used during a hip arthroscopy procedure on (b)(6) 23 when it was reported, ¿we were doing a hip arthroscopy.When the tip of the shaver he was using broke off.The tip of the oval burr broke off.Surgeon had to struggle to retrieve said piece.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.After the initial report the distributor also reported the incident but added, ¿surgeon retrieved the piece and removed out of the patient¿, so it was assured that the fragmentation was retrieved.The procedure was reported to have been completed with a 5-minute delay using an alternate same-like device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, el9101, 4.0mm oval bur, extended length, (19cm), was being used during a hip arthroscopy procedure on (b)(6) 2023 when it was reported, ¿we were doing a hip arthroscopy.When the tip of the shaver he was using broke off.The tip of the oval burr broke off.Surgeon had to struggle to retrieve said piece.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.After the initial report the distributor also reported the incident but added, ¿surgeon retrieved the piece and removed out of the patient¿, so it was assured that the fragmentation was retrieved.The procedure was reported to have been completed with a 5-minute delay using an alternate same-like device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 was 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 a total of 19 complaints, regarding 35 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 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 shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 4.0MM OVAL BUR, EXTENDED LENGTH, (19CM)
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16760448
• Report Number: 1017294-2023-00036
• Device Sequence Number: 20345340
• Product Code: GFF
• UDI-Device Identifier: 20845854012793
• UDI-Public: (01)20845854012793(17)270619(10)1253023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Model Number: EL9101
• Device Catalogue Number: EL9101
• Device Lot Number: 1253023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic