MAUDE Adverse Event Report: BRASSELER USA SMALL BONE BLADE OSCILLATING & SAGITTAL - THICK AGGRESSIVE CUT / 9.0 X 25.0MM 0.

Catalog Number	5009093M0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brasseler is reporting this alleged product malfunction in an abundance of caution.The allegations of malfunction have not been confirmed due to the inability of brasseler to perform an investigation of the product which was not returned by the customer.Brasseler will follow up with a supplemental report if more information becomes available.
Event or Problem Description
Scrub tech and circ nurse confirmed the blade(s) loaded and locked into the stryker saw properly as usual, no issues.The blade was then used to cut the patella bone with no issues.It was when the surgeon attempted to cut the tibia bone that the blade broke.Scrub tech mentioned that at one point the blade stopped moving though she could hear the saw engaging when the trigger was pulled.Then shortly after, blade broke at the crescent portion of the hub.Changed saw and used another one of these blades, and the same occurred.No portions of the blade fell into the patient.

• Brand Name: SMALL BONE BLADE OSCILLATING & SAGITTAL - THICK AGGRESSIVE CUT / 9.0 X 25.0MM 0.
• Common Device Name: BONE 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: 18144387
• Report Number: 2025102-2023-00004
• Device Sequence Number: 7540378
• Product Code: GFA
• UDI-Device Identifier: 00887919507611
• UDI-Public: 00887919507611
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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 Catalogue Number: 5009093M0
• Device Lot Number: NX7XD
• 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: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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