MAUDE Adverse Event Report: CONMED CONMED; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	00507116100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
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
The customer reported that the device, 00507116100, oscillator blade, 25.4 x 90 x 1.27 mm (.050"), was being used during a total knee replacement procedure on (b)(6) 2025 when it was reported, ¿total knee replacement was in progress when we noticed a piece of metal lodged in the tibial bone.".The ¿power tool as it was the last equipment used in the tibia¿ was checked and ¿close inspection shows that two (both ends) of the saw blade teeth had come off.¿ ¿the knee joint was washed numerous times in an attempt to flush the metal piece, but with negative results.¿ ¿the surgeon decided to give up the search and wrote in his operation notes about the incident.¿ ¿post-operative x-ray shows no metal piece is left on the patient's knee.¿ there reporter states that there is no metal left in the patient¿s knee confirmed by x-ray.The procedure was completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was 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.(b)(4).Per the instructions for use, the user is advised 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.Avoid contact of blades and burs with cutting blocks, retractors or other instrumentation.Damage to blade, bur or instrumentation may occur.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, 00507116100, oscillator blade, 25.4 x 90 x 1.27 mm (.050"), was being used during a total knee replacement procedure on (b)(6) 2025 when it was reported, "total knee replacement was in progress when we noticed a piece of metal lodged in the tibial bone." the "power tool as it was the last equipment used in the tibia" was checked and ¿close inspection shows that two (both ends) of the saw blade teeth had come off." "the knee joint was washed numerous times in an attempt to flush the metal piece, but with negative results." "the surgeon decided to give up the search and wrote in his operation notes about the incident." "post-operative x-ray shows no metal piece is left on the patient's knee." there reporter states that there is no metal left in the patient's knee confirmed by x-ray.The procedure was completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: CONMED
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• 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: 24129434
• Report Number: 1017294-2026-00010
• Device Sequence Number: 16049132
• Product Code: GFA
• UDI-Device Identifier: 10845854006382
• UDI-Public: (01)10845854006382(17)300723(10)1481337
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 00507116100
• Device Lot Number: 1481337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic