MAUDE Adverse Event Report: ARTHREX, INC. CURETTE, RING 3.4MM, CUTTING BOTH SIDE; MANUAL INSTR, GENERAL SURGICAL

Model Number	CURETTE, RING 3.4MM, CUTTING BOTH SIDE
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
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
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-21020 curette ring is cracked.The issue occurred during the case and was taken out of service immediately.The patient was not affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Functional testing was not performed on the returned ar-21020 due to the damage to the tip of the device.Visual evaluation noted that the curette ring is broken.The most likely cause is attributed to misuse due to use error.Refer to the investigation photos.

• Brand Name: CURETTE, RING 3.4MM, 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: 18013429
• Report Number: 1220246-2023-08398
• Device Sequence Number: 15273120
• Product Code: MDM
• UDI-Device Identifier: 00888867026056
• UDI-Public: 00888867026056
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• 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: CURETTE, RING 3.4MM, CUTTING BOTH SIDE
• Device Catalogue Number: AR-21020
• Device Lot Number: 10312222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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