MAUDE Adverse Event Report: ARTHREX, INC. BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0; POWERED SURG ORTHOPEDIC INSTR

Model Number	BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
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 05/05/2023, it was reported by a sales representative via email that an ar-300l (battery pack for ar-300 li-ion) exploded and was stuck in ar-300lbh (li-ion battery housing for ar-300).This was detected at an unspecified time on 05/05/2023 with no case involvement.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to environmental due to moisture intrusion.Per dfu-0223-eo revision 0, precautions: 6.The battery packs are not to be cleaned and disinfected in a thermo washer disinfector 9.Liquid on the battery and handpiece contacts may damage the device.Before connecting the battery housing, ensure the receptacles are clean and dry.
Additional Manufacturer Narrative
The complaint allegation is not confirmed.Based on the images provided from the field, arthrex concluded a most likely cause.This failure can be attributed to misuse caused by a user mishandling, such as attempting to remove the stabmagnet d3x4 from its housing - or the use of excessive force.The failure mode of the complaint allegation is deduced to be rapid disassembly of the pack housing.

• Brand Name: BATTERY PACK,UNSTRL,LI-ION FOR AR-300MD0
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17022998
• Report Number: 1220246-2023-06805
• Device Sequence Number: 6872649
• Product Code: HWE
• UDI-Device Identifier: 00888867100145
• UDI-Public: 00888867100145
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 12/19/2024

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-300MD0
• Device Catalogue Number: AR-300L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 10/07/2024; 12/17/2024
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 10/15/2024; 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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