MAUDE Adverse Event Report: BRASSELER U.S.A. MEDICAL, LLC KM-250R 60.0 X 6.33MM RECIP 0.64MM MAT THK / 1.04MM CUT THK; SAW BLADE

Catalog Number	5003673M0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received an image of the product on (b)(6) 2024.Image shows blade is bent laterally.For the investigation, reviewed ifu on lateral force.Per ifu-0035 rev e busa eu consumable accessories ifu "do not use excessive, lateral, twisting or bending forces to prevent consumable accessory failure such as bending or breakage." reviewed manufacturing dhr for in-process and final inspection dimensions and material receipt for material composition.Both were found within specification when reviewed with drawing.The blade is a reciprocating sawblade intended for forward / backward motion.Reviewing of image shows use of excessive lateral force causing blade to bend in unintended design.The most likely root cause is user error from attempting to use the blade incorrectly.
Event or Problem Description
While performing a hip replacement, the blade bent during surgery.There was no injury.

• Brand Name: KM-250R 60.0 X 6.33MM RECIP 0.64MM MAT THK / 1.04MM CUT THK
• Common Device Name: SAW BLADE
• Manufacturer (Section D): BRASSELER U.S.A. MEDICAL, LLC; 1 brasseler blvd; savannah GA 31411
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 19510304
• Report Number: 2025102-2024-00006
• Device Sequence Number: 3455651
• Product Code: GFA
• UDI-Device Identifier: 00887919434689
• UDI-Public: 00887919434689
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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 Catalogue Number: 5003673M0
• Device Lot Number: NZ0G6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown