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

Model Number	MICRO SUTURELASSO, LARGE CURVE
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/29/2023, it was reported by an arthrex subsidiary employee via (b)(4) that (2) ar-8702 micro suturelassos wire loops were difficult to advance.There was no additional information provided, and additional information has been requested.
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
Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Complaint is not confirmed.One unpackaged ar-8702 was received for evaluation.Visual inspection did not find issues with the returned device.Functional testing was done by inserting a testing suture lasso, which was not resistant.The suture lasso was passed without resistance.- moved back and forth without difficulty.The most likely cause of the reported issue is a user error.
Event or Problem Description
Additional information was provided on (b)(6) 2023, where the arthrex subsidiary employee stated this occurred during operation check before use and was not used in a tfcc repair case.A new ar-8702 was used to proceed.

• Brand Name: MICRO SUTURELASSO, LARGE 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: 18408990
• Report Number: 1220246-2023-09688
• Device Sequence Number: 2673736
• Product Code: LXH
• UDI-Device Identifier: 00888867044746
• UDI-Public: 00888867044746
• 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): 08/16/2024

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, LARGE CURVE
• Device Catalogue Number: AR-8702
• Device Lot Number: 3010128106
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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