MAUDE Adverse Event Report: ARTHREX, INC. BATTERY PACK,UNSTRL,LI-ION FOR AR-600; POWERED SURG ORTHOPEDIC INSTR

Model Number	BATTERY PACK,UNSTRL,LI-ION FOR AR-600
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
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
On (b)(6) 2024, it was reported by a facility representative via (b)(4 )that an ar-600l battery pack housing was completely split and apart.This was discovered after a fracture procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-600l serial/batch number 04113 was received for evaluation.Functional testing was not performed due to damage.A visual inspection indicated that the housing was broken.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: BATTERY PACK,UNSTRL,LI-ION FOR AR-600
• 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: 19143180
• Report Number: 1220246-2024-02162
• Device Sequence Number: 15443921
• Product Code: HWE
• UDI-Device Identifier: 00888867110946
• UDI-Public: 00888867110946
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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-600
• Device Catalogue Number: AR-600L
• Device Lot Number: GB7637662
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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