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

Catalog Number	00507118100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
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 sales representative reported on behalf of the customer that the 00507118100, 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty 5 was being used on 11sep23 and ¿three burs broke while in use¿.After further assessment it was found, "during ptg surgery, a tooth of the blade breaks when cutting the femur and the piece is recovered intra-articular.¿.There was no impact/injury, medical intervention or prolonged hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The evaluation of returned used blade, item 00507118100, qty of 35 found only one of the blades has one broken tooth.The broken tooth was not returned.A total of 34 blades that were returned are still in new condition, not previously used.The damaged condition of the returned blade is indicative of heavy use and/or the application of excessive force during use.A two-year lot history review was conducted and found a total of 105 devices reported for this lot number; however, one was confirmed.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.(b)(4).Per the instructions for use, the user is advised the following: 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.The user is also advised to avoid contact of blades and burs with cutting blocks, retractors or other instrumentation.Damage to the blade, bur or instrument may occur.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 00507118100, 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty 5 was being used on (b)(6) 2023 and "three burs broke while in use".After further assessment it was found, "during ptg surgery, a tooth of the blade breaks when cutting the femur and the piece is recovered intra-articular." there was no impact/injury, medical intervention or prolonged hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 17819355
• Report Number: 1017294-2023-00087
• Device Sequence Number: 20358661
• Product Code: GFA
• UDI-Device Identifier: 10845854009086
• UDI-Public: (01)10845854009086(17)280125(10)1295728
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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 Catalogue Number: 00507118100
• Device Lot Number: 1295728
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic