MAUDE Adverse Event Report: ARTHREX, INC. MOTOR WITH CABLE 3.5M; POWERED SURG ORTHOPEDIC INSTR

Model Number	MOTOR WITH CABLE 3.5M
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-300b burr attachment of the mis handpiece lost connection and stopped working to the ar-200m motor with cable from the console during a case while the surgeon was making an osteotomy.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 08/14/2024: this occurred during an osteotomy procedure on (b)(6) 2024.The case was completed using the complaint devices, ar-300b burr attachment of the mis handpiece and the ar-200m motor with cable by unplugging and replugging.There was a case delay, and the length of time and whether additional anesthesia was administered to the patient is unknown.There were no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the most likely cause of the reported failure can be attributed to user error of the device due to improper device handling during cleaning and sterilization.

• Brand Name: MOTOR WITH CABLE 3.5M
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20145791
• Report Number: 1220246-2024-07372
• Device Sequence Number: 20932012
• Product Code: HWE
• UDI-Device Identifier: 00888867200708
• UDI-Public: 00888867200708
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: MOTOR WITH CABLE 3.5M
• Device Catalogue Number: AR-200M
• Device Lot Number: 15056485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown