MAUDE Adverse Event Report: ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SHAVER HP, APSII, HAND CONTROL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2024, it was reported by a sales representative via (b)(4) that an ar-8330h shaver's button function are reversed, and the cord is cut exposing the wires.Discovered during a case, device swapped, and case completed with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint is not confirmed as the device was not received for evaluation, and no pictures of the failure were received.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The device¿s manufacturing date is 2019.

• Brand Name: SHAVER HP, APSII, HAND CONTROL
• 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: 20926306
• Report Number: 1220246-2024-08850
• Device Sequence Number: 20094502
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: (01)00888867043237(11)190118(10)10267952
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• 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): 01/29/2025

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, APSII, HAND CONTROL
• Device Catalogue Number: AR-8330H
• Device Lot Number: 10267952
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2019
• 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