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

Catalog Number	V130-089-90
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed korea reported on behalf of the customer that the v130-089-90 oscillating saw blade 13 x 0.89 x 90 mm device, was being used during a total knee arthroplasty procedure on (b)(6) 2025 when it was reported, ¿the handpiece connection portion of the saw blade used during total knee arthroplasty fractured.The broken fragment was handled according to the count discrepancy procedure, and the fragment was found on the operating room floor.It is assumed that the blade fractured during sawing and that the fragment was ejected outside the surgical field.The complaint product and the fragment were discarded by the hospital.No fragments remained in the patient's body.There was an approximate 2 min delay in the surgery.A replacement product was used to complete the surgery successfully, and the patient's condition was stable.¿.Further assessment questioning found that the customer has confirmed that no fragment was found inside of the patient¿s body but just found it on the floor.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient.However, conmed korea has decided to report this event to their health authorities and therefore, conmed will be filing this event to the fda.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 can not 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 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 19 complaints, regarding 19 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 to not stall handpieces, damage can occur.Precaution: when operating the powerpro electric ii oscillator handpiece, let the saw blade do the cutting.Too much force will bind the blade which can damage the handpiece.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; 525 french road; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 23978200
• Report Number: 1017294-2026-00002
• Device Sequence Number: 10716979
• Product Code: GFA
• UDI-Device Identifier: 10845854021293
• UDI-Public: (01)10845854021293(17)230929(10)1416050
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 01/06/2026

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: V130-089-90
• Device Lot Number: 1416050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic