MAUDE Adverse Event Report: ARTHREX, INC. ARTHROSCOPY PUMP REMOTE; ARTHROSCOPE AND ACCESSORIES

Model Number	ARTHROSCOPY PUMP REMOTE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/12/2024, it was reported by a sales representative via (b)(4) that an ar-6495 pump remote is not working properly.Discovered during a shoulder scope procedure with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/12/2024, a sales representative via (b)(4) reported that an ar-6495 pump remote was not working properly.The rinse and lavage buttons appear to do the opposite function.This was discovered during a shoulder scope procedure with no patient harm.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.One unpackaged ar-6495 with serial/batch number (b)(6) was received for evaluation.Upon visual inspection, it was discovered that the device¿s connector sheath was damaged and loose.Functional testing with the console found no issues pressing the lavage and rise buttons; they work as intended.However, it was observed that the keypad signs disappear from the console screen, most likely due to the damaged cable connector.No related to the allegation problem was found.

• Brand Name: ARTHROSCOPY PUMP REMOTE
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• 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: 20880374
• Report Number: 1220246-2024-08764
• Device Sequence Number: 20753972
• Product Code: HRX
• UDI-Device Identifier: 00888867419216
• UDI-Public: (01)00888867419216(11)230201(10)15051376
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• 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): 01/29/2025

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: ARTHROSCOPY PUMP REMOTE
• Device Catalogue Number: AR-6495
• Device Lot Number: 15051376
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided; 01/03/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/12/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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