MAUDE Adverse Event Report: JEIL MEDICAL CORPORATION VALKYRIE® - POWER DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	01-03-3035
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that a valkyrie disposable power driver (ref.No.(b)(4), lot no.250021-1345, expiration date: 02/23/2028) malfunctioned during use in a coronary artery bypass graft (cabg) procedure.The device did not function as intended while being used by the surgeon.The driver was removed from the surgical field, and a replacement device was opened and used to continue the procedure.No patient injury was reported.
Additional Manufacturer Narrative
A device malfunction was reported in which the device did not perform as intended.No clinical signs or symptoms were reported, and there were no health consequences associated with the event.The device was not available for evaluation; therefore, the investigation was limited to a review of available information, including event details and relevant records.No definitive findings were identified that could explain the reported malfunction.As a result, a specific root cause could not be determined based on the information available at this time.

• Brand Name: VALKYRIE® - POWER DRIVER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): JEIL MEDICAL CORPORATION; 812-ho, 55, digital-ro 34-gil; guro-gu; seoul, 08378 ; KS 08378
• Manufacturer (Section G): JEIL MEDICAL CORPORATION; 812-ho, 55, digital-ro 34-gil; guro-gu; seoul, 08378 ; KS 08378
• Manufacturer Contact: jisoo koh ; 812-ho, 55, digital-ro 34-gil; guro-gu; seoul, 08378 ; KS 08378
• MDR Report Key: 24218420
• Report Number: 3004049923-2026-00001
• Device Sequence Number: 18451252
• Product Code: KIJ
• UDI-Device Identifier: 08806390899796
• UDI-Public: (01)08806390899796(10)250021-1345(17)280223
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: 01-03-3035
• Device Lot Number: 250021-1345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown