MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a labrum slap repair shoulder surgery the lasso wire of the device was bent and due to the lack of stiffness the lasso wire could not be pushed further.No part of the device broke inside the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-4068-25tr, batch 0247106222 along with seven packaged devices of the same part/lot combination were received for investigation.Visual inspection identified that the lasso wire returned with the unpackaged sample was damaged proximal to the loop, impeding proper device functionality.A fresh sample was opened and did not present the same issues.The new device operated as intended.As such, the observed condition is consistent with misuse by the end user, most likely via mishandling.

• Brand Name: SUTURELASSO, 25 DEGREE TIGHT 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: jared engle ; 8009337001
• MDR Report Key: 19163803
• Report Number: 1220246-2024-02241
• Device Sequence Number: 7330504
• Product Code: LXH
• UDI-Device Identifier: 00888867031449
• UDI-Public: 00888867031449
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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 Expiration Date: 08/31/2025
• Device Model Number: SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT
• Device Catalogue Number: AR-4068-25TR
• Device Lot Number: 0247106222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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