MAUDE Adverse Event Report: IMEDICOM CO., LTD. BRASSELER EZX BLADE; INSTRUMENT, SURGICAL, ORTHOPEDIC

Model Number	BRXTB530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Left total hip revision, brasseler ezx blade opened to sterile field.While surgeon using inside left hip blade broke.All pieces retrieved from left hip.C-arm was offered, but surgeon determined all pieces retrieved and no need for imaging.
Additional Manufacturer Narrative
After receiving medwatch report mw5182731 via our u.S.Agent, we requested additional information from the importer.However, no further details have been provided to date.Although no patient injury was reported, device retrieval has been requested for evaluation.

• Brand Name: BRASSELER EZX BLADE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC
• Manufacturer (Section D): IMEDICOM CO., LTD.; #612, #709, #713, #804, #809,; #815, 172, ls-ro,; gunpo-si, gyeonggi-do 15807 ; KS 15807
• Manufacturer (Section G): IMEDICOM CO., LTD.; #612, #709, #713, #804, #809,; #815, 172, ls-ro,; gunpo-si, gyeonggi-do 15807 ; KS 15807
• Manufacturer Contact: jeongseop keum ; #612, #709, #713, #804, #809,; #815, 172, ls-ro,; gunpo-si, gyeonggi-do 15807 ; KS 15807
• MDR Report Key: 24636771
• Report Number: 3009599228-2026-00001
• Device Sequence Number: 8689080
• Product Code: HWE
• UDI-Device Identifier: 00887919859130
• UDI-Public: 887919859130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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
• Device Model Number: BRXTB530
• Device Catalogue Number: N/A
• Device Lot Number: BHA25052708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female