MAUDE Adverse Event Report: CONMED LARGO NEXGEN OSCILLATOR BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5071-201
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
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.Device not yet received.
Event or Problem Description
The customer reported that the device, 00507120100, nexgen oscillator blade, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿teeth blade broke off ¿ nurse looked and was able to find the piece.No impact to the patient.¿.There was no report of injury, medical intervention, or hospitalization for the user.Further assessment questions have been sent to the reporter; however, to date no response has been received.Fragmentation is reported as having been found and we have not received any notification that fragmentation was left in the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the returned used device, found machined bur teeth damage, broken off.Excessive force (load) was used during procedure.This is a technique dependent device.At this time the root cause of the event cannot be determined, but based on the evaluation and photos provided, a likely cause of this issue is that excessive force was used during the procedure.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 23 complaints, regarding 29 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: to not use burs for plunge cutting.Injury or damage may occur.Do not use saw blades to pry, remove bone grafts, or as a leverage point.Do not apply excessive bending or twisting force to blade.Patient or user injury may occur.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, 00507120100, nexgen oscillator blade, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿teeth blade broke off ¿ nurse looked and was able to find the piece.No impact to the patient.¿.There was no report of injury, medical intervention, or hospitalization for the user.Further assessment questions have been sent to the reporter; however, to date no response has been received.Fragmentation is reported as having been found and we have not received any notification that fragmentation was left in the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: NEXGEN OSCILLATOR BLADE
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 16617422
• Report Number: 1017294-2023-00023
• Device Sequence Number: 6164770
• Product Code: GFA
• UDI-Device Identifier: 10845854004982
• UDI-Public: (01)10845854004982(17)271213(10)1288928
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 5071-201
• Device Catalogue Number: 00507120100
• Device Lot Number: 1288928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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