MAUDE Adverse Event Report: BRASSELER MEDICAL, LLC KM3-111 25.0 X 9.0 MM; SMALL BONE BLADE

Model Number	KM3-111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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 confimed due to the inability of brasseler to perform an investigation on the blade which was not returned by the customer.The customer reported the broken saw blade, no product is being returned; however, the lot number and a picture was provided for evaluation.Review of the photo shows breakage occurred at the hub where the product attaches to hand piece.Review of dhr n00d4 shows product was measured within specification, and raw material 31386, and 10011 are the correct hardness and material type.This is the only complaint for this product.
Event or Problem Description
During an acl repair, the blade broke when trying to cut the patella.It broke at the base of the blade where the blade attaches to the power system.The product was completely removed from the patient.There was no injury.

• Brand Name: KM3-111 25.0 X 9.0 MM
• Common Device Name: SMALL BONE 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: 20887735
• Report Number: 2025102-2024-00011
• Device Sequence Number: 8934269
• Product Code: GFA
• UDI-Device Identifier: 00887919445869
• UDI-Public: (01)00887919445869(17)290816(10)N00D4
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: KM3-111
• Device Lot Number: N00D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/09/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American