MAUDE Adverse Event Report: BRASSELER MEDICAL, LLC KM3-111 25.0 X 9.0MM 0.51MM MAT THK / 0.56MM CUT THK; SAW BLADE

Model Number	00887919445869
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brasseler is reporting the alleged malfunction in an abundance of caution.The allegations of malfunction have not been confirmed due to the inability of brasseler to perform an investigation on the blade which was not returned by customer.
Event or Problem Description
The doctor was using the blade for an acl repair surgery, cutting tibia and patella for btb autograft.The blade broke at the hub.They continued to use the same part number, and the other blades broke as well during this procedure.The reported number of blades broken varied from four to five.These blades, and their packaging, were discarded.There was no injury.

• Brand Name: KM3-111 25.0 X 9.0MM 0.51MM MAT THK / 0.56MM CUT THK
• Common Device Name: SAW BLADE
• Manufacturer (Section D): BRASSELER MEDICAL, LLC; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 21699964
• Report Number: 2025102-2025-00002
• Device Sequence Number: 8593358
• Product Code: GFA
• UDI-Device Identifier: 00887919445869
• UDI-Public: 00887919445869
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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 Model Number: 00887919445869
• Device Catalogue Number: KM3-111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Hispanic
• Patient Race: White