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	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/30/2025, it was reported by a sales representative via (b)(6) that an ar-7300ds dissector has wear marks at the shp connection.The photo provided by the sales rep showed discoloration along the shaft of the dissector.Per the sales rep, the other devices being used with the dissector were ar-8330h shaver handpiece, an ar-8305 synergy shaver console, and an ar-8310 shaver footswitch.This was discovered during a case with no patient involvement.Additional information was received via medwatch on 10/10/2025: a facility representative reported that an ar-8305 synergy resection shaver console was used during a procedure on (b)(6) 2025.After the surgeon removed the arthroscopic shaver from the patient and was about to place it on the mayo stand, the surgical team observed that the device remained active despite the switch being turned off.Additional information was received via phone on 10/15/2025: per the rep, the event occurred outside the patient, on the mayo stand, after the ar-7300ds had been used and was no longer required for the procedure.It is unknown how long the ar-7300ds was used continuously, and whether any wear marks were present at the proximal end where it connects to the ar-8330h shaver handpiece.No adverse effects were reported during or after the surgery.Due to this issue, there were no injuries to the patient, surgeon, or staff.The incident occurred following a lateral ankle reconstruction procedure.The case was completed successfully without any delays or additional anesthesia.
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 device was not received for evaluation.Based on the information provided, including the device (if available and returned), photographs, videos, event descriptions, and additional field information, arthrex concluded that the most likely cause of the reported failure included user error, such as the possibility that the handswitch was not fully turned off, resulting in unintended activation.The wear and tear of the device's mechanism accumulated through repetitive use and reprocessing.The device was manufactured on august 17, 2018 direction for use dfu-0154-eo revision 6.Synergy and adapteur power system ii (aps ii) shaver handpieces.G.Validation repeated processing has minimal effect on these devices when processed as recommended within these instructions.End of service life is normally determined by wear and damage due to repeated use.The user assumes liability and is responsible for the use of a damaged and/or dirty device.The complaint allegation cannot be confirmed.The device was not received for physical and functional evaluation, and no evidence of the device failure was provided.

• 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: 23429803
• Report Number: 1220246-2025-04914
• Device Sequence Number: 8280833
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: (01)00888867043237(11)180817(10)10256837
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 10256837
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown