MAUDE Adverse Event Report: BRASSELER USA K7-1990-50 90.0 X 19.0 MM 1.27+; SAW BLADE

Model Number	5010175M0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is consistent with a previous investigation that was performed for a similar product failure.There were deep gouges on the top and bottom surfaces of the blade that are consistant with excess torque being applied.In addition, there are indentations on the sides of the blade and rounding on the teeth that would indicate the blade made contact with something harder than bone.Monitoring of this type of failure, this does not represent a trend, we will continue to monitor.Reporting out of an abundance of caution.
Event or Problem Description
The customer reported that a large bone blade broke while making femoral cuts in a total knee procedure while making the femur cut.The patient was not injured.Medwatch form 5115967 was received.

• Brand Name: K7-1990-50 90.0 X 19.0 MM 1.27+
• Common Device Name: SAW BLADE
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 16742222
• Report Number: 2025102-2023-00001
• Device Sequence Number: 20192474
• Product Code: GFA
• UDI-Device Identifier: 00887919526230
• UDI-Public: 00887919526230
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 5010175M0
• Device Catalogue Number: 5010175M0
• Device Lot Number: NW5J8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White