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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 06-mar-2026, it was reported by a sales representative via (b)(4) that an ar-8330h shaver hand piece was damaging burs while in use.It was replaced with another hand piece and that one worked perfectly.The case was completed without any effect to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Visual comments and observed conditions: cable: no visual defects identified; no problem found.Functional evaluation: device ar-8330h, s/n (b)(6) was subjected to functional testing per wi-000100858.The device was tested with a known good shaver console unit (scu) and passed all performance requirements and functioned without any issues.Specifically, collet function testing did not find any issues related to attachment/burr connection and functioned appropriately.In reference to the customer's complaint, "ar-8330h shaver hand piece was damaging burrs while in use;" since investigative findings were not able to replicate the customer's complaint, the complaint will be considered not confirmed.

• 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: 24701065
• Report Number: 1220246-2026-01678
• Device Sequence Number: 10557216
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: (01)00888867043237(11)170328(10)10152616
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/09/2026

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, APSII, HAND CONTROL
• Device Catalogue Number: AR-8330H
• Device Lot Number: 10152616
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown