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

Model Number	90 DEG CURVE RIGHT, QUICKPASS LASSO
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
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 01/19/2024, it was reported by an arthrex subsidiary employee via (b)(4) during a lamp procedure on (b)(6) 2024, the surgeon was trying to use a quickpass lasso, ar-6068-90r, but could not use it because the wire was not fed no matter how many times they turned the handle.The case was completed with a new product of the same part number with no adverse effect to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is not confirmed.One unpackaged ar-6068-90r batch 2035119190, was received for evaluation.Visual evaluation noted marks on the wheel grip lasso equivalent to excessive pressure trying to pass the suture through the wheels.Functional testing with an ar-7222 batch 30084 found no resistance when the suture was introduced slowly, and the wheel moved softly without pressure.The suture passed until it came out of the tip¿no problem found.The most likely cause of the reported event is a user error following the device's surgical technique.According to dfu-0222-eor1_fmt_en.G.Precautions.1.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also offers detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.2.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

• Brand Name: 90 DEG CURVE RIGHT, QUICKPASS LASSO
• 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: jared engle ; 8009337001
• MDR Report Key: 18696569
• Report Number: 1220246-2024-00939
• Device Sequence Number: 12564053
• Product Code: LXH
• UDI-Device Identifier: 00888867038967
• UDI-Public: 00888867038967
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/03/2025

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 Model Number: 90 DEG CURVE RIGHT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90R
• Device Lot Number: 2035119190
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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