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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the back part of the device became hot.There was no harm for patient, operator or third party reported.This was noticed before the surgery.No further information received.Update avoe 11-apr-2022: it was confirmed that the error occurred on the 04-apr-2022 during a hip surgery.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that during a surgery the back part of the device became hot.The suppliers evaluation revealed the reported event was attributed to the mating handpiece ar-600, sn (b)(6).There was no issue found with the battery packs that had been used along with the handpiece.

• 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: 19499425
• Report Number: 1220246-2024-05421
• Device Sequence Number: 12465583
• 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
• Report Date (Section B): 06/10/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown