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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
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 7/5/2023, it was reported by a sales representative via sems that an ar-21020 curette had an issue.During the surgery, the surgeon was preparing the glenoid for a labral repair, and while using the curette, it broke when it made contact with the bone and snapped in half.The broken piece was retrieved from the joint, and the case was continued without the patient being affected.This occurred during use in a labral repair procedure with no patient harm.Additional information has been requested.On 7/18/2023, the sales representative stated the following information via phone: this event occurred during a labral repair procedure on (b)(6) 2023.After the broken piece had been retrieved, a new ar-21020 curette with an unknown lot number was used to complete the case successfully with no patient harm.There was no case delay or any adverse effect to the patient reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-21020, serial number (b)(6), was received for investigation.No functional test for this device with a broken shaft tip.The returned device was visually inspected, and it was noted that the shaft tip was broken off.The visual inspection also noted severe signs of wear on the device, as well as many scratches and discoloration throughout the body.The most likely cause for the reported failure is user error for applying excessive force during use, per dfu-0255 at revision 2.E.J.Cautions.2 to avoid damaging the instrument, do not impact or subject any instrument to blunt force.Inspection and maintenance.Ii.The metal shafts of bendable devices become stressed and may crack or fracture with continuous bending.This condition indicates the device¿s end of life and must be replaced or discarded.Inspection prior to use should include verifying the shaft is free of cracks or fractures.

• 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: 17450172
• Report Number: 1220246-2023-07405
• Device Sequence Number: 7383449
• Product Code: MDM
• UDI-Device Identifier: 00888867026056
• UDI-Public: 00888867026056
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/04/2024

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: 14933982
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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