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

Model Number	MICRO SUTURELASSO, SMALL CURVE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8701 micro suturelassos wire was stuck in the shaft.This occurred during a lateral ankle ligament repair on (b)(6) 2023; another product was used to complete the case.
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
Additional information: d9, g3, h3, h6.Complaint is not confirmed¿no problem found.One unpackaged ar-8701 was received for evaluation.Visual inspection did not find issues with the returned device.Functional testing was done by inserting a testing suture lasso.The suture lasso was passed without resistance.- moved back and forth without difficulty.No issues were found when measuring the curve distance by drawing c15036 at revision 2.The device is within tolerance.Distance.48 ±.01 (.47 -.49) result:.47 in.The most likely cause of the reported issue is a user error.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18103713
• Report Number: 1220246-2023-08645
• Device Sequence Number: 5556080
• 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): 11/21/2024

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: 3047129242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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