MAUDE Adverse Event Report: ARTHREX, INC. BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0; POWERED SURG ORTHOPEDIC INSTR

Model Number	BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
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
It was reported that during a small joint surgery the new battery ar-300l (sn: (b)(6)) damaged the new handpiece ar-300 (sn: ).A battery error was displayed and the motor of the device ar-300 didn`t start.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 19-jun-2024 it was confirmed that new battery  pack caused  defect of the handpiece.The control board had no function  due of short circuit not mechanical damaged.In combination with the battery  the error code 01 was displayed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the manufacturer evaluation revealed the battery pack itself did not present with any kind of damages, but it was observed that the fuse was triggered and is now defective.It is assumed that the handpiece had a defect and therefore triggered the fuse.As the battery has no electronics, no measured values could be recorded.All individual components worked according to specification and the fuse was triggered by incorrect use of the battery.

• Brand Name: BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0
• 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: 19729265
• Report Number: 1220246-2024-06716
• Device Sequence Number: 8033216
• Product Code: HWE
• UDI-Device Identifier: 00888867100145
• UDI-Public: 00888867100145
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0
• Device Catalogue Number: AR-300L
• Device Lot Number: 15156003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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