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

Model Number	RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic ankle fusion surgery the tip of the curette broke off in the joint.All broken parts were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-8655-02).It was not necessary to switch the surgical technique or do a second surgery.
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
Complaint allegation is confirmed.Upon visual inspection, it was noted that the ring currette at the distal end of the shaft of the ring currette, ankle, arthroscopy, reverse angled was broken off.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were provided.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufacturing date 2018.

• Brand Name: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• 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: 18573718
• Report Number: 1220246-2024-00503
• Device Sequence Number: 15386869
• Product Code: MDM
• UDI-Device Identifier: 00888867044272
• UDI-Public: 00888867044272
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/28/2024

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: 1391831
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown