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	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 10/10/2025, it was reported by a sales representative via (b)(6) that an ar-8330h shaver handpiece "shocked" the operator when in use.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received 11/24/2025 that there was not any exposed wiring, the shock did not require any medical treatment, it was not prolonged and the environment was not dry.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation: no visual defects were noted.Functional evaluation: the device was subjected to functional testing per (b)(4), section 6.3.All requirements were met.A water leak test was performed per (b)(4) no leakage noted.The device was subjected to a continuity test in order to test for electrical shorts.None were found.An electrical safety test was also performed using a known, good shaver console.No issues were identified.(refer to engineering_memo_case (b)(4), attached.) further examination was performed in an attempt to recreate the event reported by the customer.Again, no issues were noted.(refer to mtf-mdr-case-(b)(4), attached.) the reported event is not confirmed.It is plausible that the customer's experience was the result of electrostatic discharge.This would result from clothing (e.G.Scrubs, smocks) that allow for the buildup of a negative charge through friction, creating a voltage potential difference between the individual and any conductive metal on the disconnected device.

• 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: 23498986
• Report Number: 1220246-2025-05032
• Device Sequence Number: 21080989
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: (01)00888867043237(11)180215(10)10189342
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 01/16/2026

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: 10189342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Distributor Facility Aware Date: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 01/15/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown