MAUDE Adverse Event Report: CONMED LARGO 19.5 X 95 X 0.9MM (.035INCH) OSCILLATOR BLADE, 5 EA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	00507112000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided that confirmed the reported issue.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 20 reports, regarding 26 devices, for this device family and failure mode.During this same time frame 1,761,231 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 0.00001.Per the 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.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 00507112000, 19.5 x 95 x 0.9mm (.035inch) oscillator blade was being used on (b)(6) 2022 during an unknown procedure and broken saw blade.Pulling metals pieces out of patient.All pieces recovered procedure completed.Patient required an x-ray to confirm all pieced removed.There was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.There was a 20-30 minute delay to the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 19.5 X 95 X 0.9MM (.035INCH) OSCILLATOR BLADE, 5 EA
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15410478
• Report Number: 1017294-2022-00093
• Device Sequence Number: 12172362
• Product Code: GFA
• UDI-Device Identifier: 20845854000288
• UDI-Public: (01)20845854000288(17)270117(10)1220918
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/13/2022

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 Catalogue Number: 00507112000
• Device Lot Number: 1220918
• 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: 08/25/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic