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 Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/29/2023, it was reported by a facility representative via (b)(6) that an ar-600l battery pack housing was split along the seams.This was discovered during the battery removal after the case, with no patient harm.
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.
Additional Manufacturer Narrative
Complaint is confirmed.After a visual investigation of the plastic housing detached from the plastic base, it was noted that the ultrasonic welding of the entire battery was broken and opened.The most likely cause of the reported failure is a user error or the device's drop due to the broken ultrasonic welding.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18011854
• Report Number: 1220246-2023-08390
• Device Sequence Number: 7313957
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: 09/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown