MAUDE Adverse Event Report: ARTHREX, INC. MICRO SUTURELASSO, SMALL CURVE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MICRO SUTURELASSO, SMALL CURVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex subsidiary employee via sems (b)(4) that two ar-8701 suturelassos wires broke when pulling the thread.This case was completed with a new product of the same catalog number.No patient harm.
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
The complaint allegation was confirmed.One unpackaged ar-8701 batch number 3241134581 was received for investigation visual inspection revealed that the nitinol wire was broken.Functional testing was performed by inserting a piece of nitinol wire through the shaft, and no resistance was encountered.The most probable cause of reported failure is excessive force during use.

• Brand Name: MICRO SUTURELASSO, SMALL CURVE
• 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: 19262306
• Report Number: 1220246-2024-02912
• Device Sequence Number: 6493289
• Product Code: LXH
• UDI-Device Identifier: 00888867044722
• UDI-Public: 00888867044722
• 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): 09/10/2024

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: MICRO SUTURELASSO, SMALL CURVE
• Device Catalogue Number: AR-8701
• Device Lot Number: 3241134581
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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