MAUDE Adverse Event Report: ARTHREX, INC. 90 DEG CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	90 DEG CURVE RIGHT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
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 (b)(6) 2023, it was reported by a sales representative via sems that qty.2 of an ar-4068-90r suturelasso sd, 90° curve right had an issue.The curve right wire would not advance out of the needle tip.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.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 for the reported failure can be attributed to user error of the device due to excessive force being used when attempting to advance the wire.
Event or Problem Description
On 9/21/2023, the sales representative provided the following information via email: this occurred during a labral repair procedure.No pieces broke off the devices.The wire would not advance in both 90° right lassos after the first pass through tissue.To finish, they opened a 90° straight and had no problem with multiple passes.The procedure was completed successfully, and there was no case delay reported.No pictures were taken, and the complaint devices were discarded.

• Brand Name: 90 DEG CURVE RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 17698238
• Report Number: 1220246-2023-07801
• Device Sequence Number: 18003757
• Product Code: LXH
• UDI-Device Identifier: 00888867031548
• UDI-Public: 00888867031548
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/18/2025

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 Expiration Date: 09/30/2025
• Device Model Number: 90 DEG CURVE RIGHT
• Device Catalogue Number: AR-4068-90R
• Device Lot Number: 0279106871
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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