MAUDE Adverse Event Report: CONMED LARGO CONMED; 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	12/24/2024
Type of Reportable Event	Malfunction
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the 00507112000, oscillator blade, 19.5 x 95 x 0.9 mm (.035") device was used in a procedure on (b)(6) 2024, and ¿during a total knee today one of the oscillating blades broke.All parts were accounted for and the patient was not injured.¿ further assessment found that "two pieces of the metal broke off the end that attached to the saw".The device fragmented and fell into the surgical site, with "all pieces were retrieved ¿ three in total." the procedure was completed with an alternate same device and a delay of approximately 5 minutes.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, who was "discharged to home".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the 00507112000, oscillator blade, 19.5 x 95 x 0.9 mm (.035") device was used in a procedure on (b)(6) 2024, and ¿during a total knee today one of the oscillating blades broke.All parts were accounted for and the patient was not injured.¿.Further assessment found that "two pieces of the metal broke off the end that attached to the saw".The device fragmented and fell into the surgical site, with "all pieces were retrieved ¿ three in total".The procedure was completed with an alternate same device and a delay of approximately 5 minutes.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, who was "discharged to home".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 was provided.Therefore, a device malfunction 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 two-year lot history review shows a total of one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 16 reports, regarding 125 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: 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 per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21129432
• Report Number: 1017294-2025-00002
• Device Sequence Number: 6807198
• Product Code: GFA
• UDI-Device Identifier: 10845854000281
• UDI-Public: (01)10845854000281(17)290910(10)1411759
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 1411759
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic