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

Model Number	SHAVER HP, SYNERGY, HANDCONTROL
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
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 12-feb-2026, a sales representative reported via (b)(4) that the ar-8332h shaver handpiece is having issues placing a blade inside.This issue was discovered during a case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Visual comments and observed conditions: cable: normal wear and tear; housing: scratches, stains and/or dents.Other: locking pin malfunction (refer to functional testing for details).Functional evaluation: device ar-8332h, s/n (b)(6) was subjected to functional testing per (b)(4).The device was tested with a known good shaver console unit (scu) and no problems were found except the locking pin testing.The investigation failure on the locking pin from the customer¿s complaint of, "(b)(4) shaver handpiece is having issues placing a blade inside," is therefore, considered confirmed.

• 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: 24519155
• Report Number: 1220246-2026-01238
• Device Sequence Number: 8504315
• Product Code: HWE
• UDI-Device Identifier: 00888867123991
• UDI-Public: (01)00888867123991(11)250701(10)15454242
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 15454242
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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