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 Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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 housing is ruptured.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
Corrections: h.1 set as n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• 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: 19142245
• Report Number: 1220246-2024-02155
• Device Sequence Number: 12721234
• Product Code: HWE
• UDI-Device Identifier: 00888867110946
• UDI-Public: 00888867110946
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/26/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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