MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-300,HANDPIECE; POWERED SURG ORTHOPEDIC INSTR

Model Number	ARTHREX AR-300,HANDPIECE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the device has a broken battery pin.The problem was noticed after surgery.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.A most likely cause is attributed to improper device handling.
Additional Manufacturer Narrative
It was reported that the device has a broken battery pin.The reported event was confirmed.The manufacturer evaluation revealed a broken pin at the control board along with bent guide pins resulting in difficulties to attach the battery housing.If the battery housing is not placed straight, it can result in a broken pin.

• Brand Name: ARTHREX AR-300,HANDPIECE
• 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: 19219746
• Report Number: 1220246-2024-02655
• Device Sequence Number: 15179393
• Product Code: HWE
• UDI-Device Identifier: 00888867099357
• UDI-Public: 00888867099357
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 03/21/2025

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: ARTHREX AR-300,HANDPIECE
• Device Catalogue Number: AR-300
• Device Lot Number: 15121198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 03/07/2025
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/20/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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