MAUDE Adverse Event Report: CONMED LARGO 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5071-181
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
Event or Problem Description
The customer reported that the 00507118100 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty 5 was being used on (b)(6) 2023 and the blade broke.The procedure was completed.After further assessment it was found that the device did fragment and fall into surgical site.The fragment was retrieved."towards the end of the procedure, the surgeon was using the tip of the blade to ¿flick¿ out bone debri and chips.In doing so the further tooth on the end of the blade broke off.It did not impact the patient or cause injury, and the broken piece was removed from the blade." this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the 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 00507118100 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty 5 was being used on (b)(6) 2023 and the blade broke.The procedure was completed.After further assessment it was found that the device did fragment and fall into surgical site.The fragment was retrieved."towards the end of the procedure, the surgeon was using the tip of the blade to ¿flick¿ out bone debri and chips.In doing so the further tooth on the end of the blade broke off.It did not impact the patient or cause injury, and the broken piece was removed from the blade." 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 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.A 2 year lot history review shows 2 events for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 8 reports, regarding 14 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: avoid contact of blades and burs with cutting blocks, retractors or other instrumentation.Damage to the blade, bur or instrument may occur.The ifu also advises the user to 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.

• Brand Name: 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5
• 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: 16684007
• Report Number: 1017294-2023-00030
• Device Sequence Number: 12609346
• Product Code: GFA
• UDI-Device Identifier: 10845854009086
• UDI-Public: (01)10845854009086(17)280104(10)1292071
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 5071-181
• Device Catalogue Number: 00507118100
• Device Lot Number: 1292071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic