MAUDE Adverse Event Report: ARTHREX, INC. RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/30/2023 it was reported by a sales representative via sems that an ar-8655-04 ring currette broke off inside the patient during the ankle arthroscopy/micro fracture repair.The tip of curette broke off inside the joint when trying to remove loose cartilage during the middle of the arthroscopy procedure.The surgeon had to open laterally since he was not able to retrieve the piece inside the joint.They used fluro to located the broken piece but still the surgeon never retrieved the broken piece.
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.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly use of the device in the field.Manufacturing date 2018.

• Brand Name: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16403787
• Report Number: 1220246-2023-06325
• Device Sequence Number: 5759709
• Product Code: MDM
• UDI-Device Identifier: 00888867044272
• UDI-Public: 00888867044272
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• Device Catalogue Number: AR-8655-04
• Device Lot Number: 1391844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown