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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual comments and observed conditions: shp cable - evidence of cut insulation exposing internal sheathing that encloses internal wires (refer to photo).No other significant visual conditions have been observed.The device ar-8332h, serial number (b)(6), was subjected to functional testing in accordance with wi-000100858.The device was tested using a known-good shaver console unit (scu) and successfully passed all functional requirements.In reference to the customer complaint reported, "ar-8332h shaver hand control exhibited a cut in the cord,¿ the observed damage is most likely attributable to use error.Therefore, the reported allegation is confirmed.
Event or Problem Description
On 18-mar-2026, a sales representative reported via (b)(4) that an ar-8332h shaver handcontrol had a cut in the cord.This was discovered during a case with no adverse effects.

• 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: 24832735
• Report Number: 1220246-2026-02105
• Device Sequence Number: 18434024
• Product Code: HWE
• UDI-Device Identifier: 00888867123991
• UDI-Public: (01)00888867123991(11)251205(10)15532425
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 15532425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown