MAUDE Adverse Event Report: CONMED LARGO OSCILLATOR BLADE, COATED, 25 X 100 X 1.19 MM, 5PK; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5071-255
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
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 sales representative reported on behalf of the customer that the 00507125500, oscillator blade, coated, 25 x 100 x 1.19 mm, 5pk, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿tooth chipped off the blade.X-ray was used to verify no metal pieces were left in the joint.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions were asked; however, no response has been received to date.An x-ray was taken to assure no metal was left in the patient and we have received no report of fragmentation being in the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date, but photographic evidence has been provided.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 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following: placing excessive bending or twisting force on the sagittal saw blade may cause the collet to open and release the saw blade.Do not use saw blades to pry, remove bone grafts, or as a leverage point.Patient or user injury could occur.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 00507125500, oscillator blade, coated, 25 x 100 x 1.19 mm, 5pk, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿tooth chipped off the blade.X-ray was used to verify no metal pieces were left in the joint.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions were asked; however, no response has been received to date.An x-ray was taken to assure no metal was left in the patient and we have received no report of fragmentation being in the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: OSCILLATOR BLADE, COATED, 25 X 100 X 1.19 MM, 5PK
• 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: 16654297
• Report Number: 1017294-2023-00028
• Device Sequence Number: 5821840
• Product Code: GFA
• UDI-Device Identifier: 20845854046019
• UDI-Public: (01)20845854046019(17)270428(10)1243029
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: 5071-255
• Device Catalogue Number: 00507125500
• Device Lot Number: 1243029
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic