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 Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
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 03/07/2025, a sales representative reported via (b)(4) that an ar-8330h shaver hp had a piece of a broken tip of an ar-8400td torpedo that could have broken off and fallen inside.The issue was discovered during the surgery.Another device was swapped, and the case was completed without adverse effects on the patient.X-rays were taken, and there were no pieces of the broken device inside the patient.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(no problem found) the evaluation did not reveal any issues relevant to the reported event, no sign of a broken tip of the ar-8400td in relation to the shp, since the tip of the attachment broke off while the hub secured in collet.

• 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: 21708118
• Report Number: 1220246-2025-01152
• Device Sequence Number: 4745630
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: (01)00888867043237(11)200818(10)11213279
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/24/2025

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: 11213279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown