MAUDE Adverse Event Report: ARTHREX, INC. CURETTE,BS CUT,Ø 5.4MM RING,220 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	CURETTE,BS CUT,Ø 5.4MM RING,220 MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is dull.There was no harm for the patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
It was reported the device is dull.The reported event was confirmed as the visual evaluation revealed that the cutter is dull (see evaluation pictures 2 + 3).A most likely cause is wear and tear.

• Brand Name: CURETTE,BS CUT,Ø 5.4MM RING,220 MM
• 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: 18005405
• Report Number: 1220246-2023-08378
• Device Sequence Number: 15363059
• Product Code: MDM
• UDI-Device Identifier: 00888867026018
• UDI-Public: 00888867026018
• 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
• Report Date (Section B): 10/25/2023

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: CURETTE,BS CUT,Ø 5.4MM RING,220 MM
• Device Catalogue Number: AR-20030
• Device Lot Number: 14992723
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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