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

Model Number	CWIII ARTHROSCOPY PUMP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation showed extensive physical damaged.It was noticed that the rubber piece of the latch door was missing.Which will not secure the front housing properly.Functional evaluation showed the unit was able to power on.No error codes.The most likely cause for the reported failure is the wear and tear damage incurred over repeated usage.
Event or Problem Description
On 01/19/2022 it was reported by a arthrex representative via sems that an ar-6475 pump displays pressure fault when in use.This was discovered during use in a procedure.No patient harm.Ts: checked with a manometer and noticed that the pressure indicated and the measured pressure is off.Requested additional information.

• Brand Name: CWIII ARTHROSCOPY PUMP
• 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: emily shafer ; 8009337001
• MDR Report Key: 18418178
• Report Number: 1220246-2023-09755
• Device Sequence Number: 20795276
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K024291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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