MAUDE Adverse Event Report: CONMED HALL; 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	01/28/2026
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 00507116100 oscillator blade, 25.4 x 90 x 1.27 mm (.050"), device was being used on (b)(6) 2026 during an unknown procedure when it was reported ¿today we had a 5071-161 break from lot: 1506918.¿.Further assessment found that the device did fragment into the surgical site and was removed.There was no report of injury, medical intervention, or extended 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 device is not being returned and the photographic evidence provided does not appear to verify the complaint; therefore, a device malfunction 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 21 complaints, regarding 21 devices, for this device family and failure mode.During this same time frame 1,726,314 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 0.00001.Per the instructions for use, the user is advised to never pinch the hall primecut cassettes.Overheating of the blade may cause damage to the cassette and may cause burns or thermal necrosis.Avoid contact of blades with cutting blocks, retractors or other instrumentation.Damage to blade or instrumentation may occur.Metal fragments may cause injury to patient or user.Do not use burs for plunge cutting.Injury or damage may occur.When using the powerpro sagittal saw attachment (pro2043), placing excessive bending or twisting force on the sagittal saw blade may cause the collet to open and release the saw blade.Do not use saw blades to pry, remove bone grafts, or as a leverage point.Do not apply excessive bending or twisting force to blade.Patient or user injury may occur.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the that the 00507116100 oscillator blade, 25.4 x 90 x 1.27 mm (.050") device was being used on (b)(6) 2026 during an unknown procedure when it was reported ¿today we had a 5071-161 break from lot 1506918.¿.Further assessment found that the device did fragment into the surgical site and was removed.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL
• 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: 24414753
• Report Number: 1017294-2026-00021
• Device Sequence Number: 5916885
• Product Code: GFA
• UDI-Device Identifier: 10845854006382
• UDI-Public: (01)10845854006382(17)301110(10)1506918
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 1506918
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic