MAUDE Adverse Event Report: BRASSELER USA; KM-97N 32.0 X 6.4 MM 0.79MM MAT THK / 1.07MM CUT THK

Catalog Number	5003979M0
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported breakage during use and returned the used blade for evaluation.Visual observations of returned product shows a broken hub.Dimensional measurable attributes on the returned piece were in specification of the drawing.Review of receipt of materials were also to specification.A possible contributing factor but not verified may be the condition of the hand piece if worn from use and not properly maintained which may have an adverse effect on performance or cause problems during use.Product not being fully seated, or using excess lateral force will cause excess stress on the instrument leading to breakage.This is the only complaint for this item to date, however brasseler will monitors for trends.
Event or Problem Description
During open heart surgery, the surgeon opened the chest & noticed one of the side arms from the saw blade broke off.A chest x-ray was taken.The missing piece was not visualized on the x-ray.No follow-up treatment was needed.The patient is doing fine.

• Common Device Name: KM-97N 32.0 X 6.4 MM 0.79MM MAT THK / 1.07MM CUT THK
• 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: 13932906
• Report Number: 2025102-2022-00005
• Device Sequence Number: 20037188
• Product Code: GFA
• UDI-Device Identifier: 00887919445500
• UDI-Public: (01)00887919445500(10)NV2P4
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: 5003979M0
• Device Lot Number: NV2P4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White