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

Model Number	SHAVER HP, SYNERGY, HANDCONTROL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder decompression surgery the shaver handpiece ar-8332h (sn: (b)(6)) damaged 2 burrs ar-8400obe (batch 15446780).They got torn up in the bottom where they attach to shaver handpiece.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The reported event was not confirmed.The service evaluation that the buttons have no function which is most likely attributed to improper device handling.The most likely cause of the reported failure is a user error, specifically the incorrect setting of the device on the handpiece or the use of an incorrect handpiece.Directions for use dfu-0215-eo revision 1 disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection and shaverdrill devices i.Device insertion and removal.To insert a disposable device, insert the device into the handpiece so that the plastic tab mates with the handpiece slot.The tab should be pushed in proximally as far as possible for a positive lock.Dfu-0154-eo revision 6 synergy and adapteur power system ii (aps ii) shaver handpieces.To insert an attachment, fully insert the hub into the hub bore of the handpiece.Watch the locking pin slide back and forth to check that it is locked in place.There will be an audible ¿click¿ sound when the handpiece is securely locked.

• 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: 23619003
• Report Number: 1220246-2025-05138
• Device Sequence Number: 9052022
• Product Code: HWE
• UDI-Device Identifier: 00888867123991
• UDI-Public: (01)00888867123991(11)240521(10)15245541
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 02/03/2026

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: 15245541
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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