MAUDE Adverse Event Report: ARTHREX, INC. SHAVER HP, SYNERGY, HANDCONTROL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SHAVER HP, SYNERGY, HANDCONTROL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/24/2025, a facility representative reported via (b)(4) that an ar-8332h synergy shaver cord was cut.The case involvement is unknown.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the evaluation confirmed the reported event and attributed it most likely due to use error.(refer to photo).

• Brand Name: SHAVER HP, SYNERGY, HANDCONTROL
• 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: 22012445
• Report Number: 1220246-2025-02033
• Device Sequence Number: 7893349
• Product Code: HWE
• UDI-Device Identifier: 00888867123991
• UDI-Public: (01)00888867123991(11)230810(10)15123702
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/12/2025

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: SHAVER HP, SYNERGY, HANDCONTROL
• Device Catalogue Number: AR-8332H
• Device Lot Number: 15123702
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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