MAUDE Adverse Event Report: ARTHREX, INC. CURRETTE, RING 5.4MM, CUTTING BOTH SIDE; MANUAL INSTR, GENERAL SURGICAL

Model Number	CURRETTE, RING 5.4MM, CUTTING BOTH SIDE
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that, during a shoulder arthroscopy, there was rust on the curette.According to the surgeon, no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device being used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual inspection identified around the distal end of the curette shaft of the returned curette, ø 5.4 mm ring, both sides cutting, w/handle had corrosion spots.Also, observed discoloration on the handle.Dfu-0023-eo warns against using devices at section d follow the instructions of the detergent manufacturer regarding use, concentration, and temperature for either manual or automated cleaning.Please use only freshly prepared solutions as well as only purified/highly purified water at least for final rinse, and a soft, low linting cloth and/or filtered medical grade air for drying, respectively.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to improper detergent/cleaning process used.

• Brand Name: CURRETTE, RING 5.4MM, CUTTING BOTH SIDE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 18147041
• Report Number: 1220246-2023-08761
• Device Sequence Number: 15338711
• Product Code: MDM
• UDI-Device Identifier: 00888867026001
• UDI-Public: 00888867026001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 11/18/2024

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: CURRETTE, RING 5.4MM, CUTTING BOTH SIDE
• Device Catalogue Number: AR-20020
• Device Lot Number: 14998308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown