MAUDE Adverse Event Report: ARTHREX, INC. RING CURETTE,ANKLE ARTHRSCPY,STR; MANUAL INSTR, GENERAL SURGICAL

Model Number	RING CURETTE,ANKLE ARTHRSCPY,STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
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 01/18/2024, it was reported by an arthrex subsidiary employee via (b)(4) that during a procedure on (b)(6) 2024, a ring curette, ar-8655-14, from the ankle arthroscopy box broke during surgery with no impact on the patient; not a single part of the instrument was left in the patient.
Additional Manufacturer Narrative
(b)(4) is a duplicate of (b)(4), both reports are of the same event.Therefore, the investigation from (b)(4) will be applied to (b)(4).Complaint allegation is confirmed.One unpackaged ar-8655-14 ring curette batch number: 1391945 was received for investigation.Visual evaluation of the returned device noted that the ring cutter was broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: RING CURETTE,ANKLE ARTHRSCPY,STR
• 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: 18635575
• Report Number: 1220246-2024-00727
• Device Sequence Number: 18115086
• Product Code: MDM
• UDI-Device Identifier: 00888867044364
• UDI-Public: 00888867044364
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/15/2024

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 CURETTE,ANKLE ARTHRSCPY,STR
• Device Catalogue Number: AR-8655-14
• Device Lot Number: 1391945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown