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

Model Number	MICRO SUTURELASSO, STRAIGHT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
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
It was reported that during an ankle surgery the micro suture lasso didn¿t work well.The nitinol wire loop was stuck at the beginning as the nitinol should be passed through the lasso.3 out of 4 times strength was required to pass the nitinol wire loop normally through the device.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, the suture-less was returned inside the driver.No damage to the device was noted.Functional testing was performed four times and revealed that the suturelasso passed through the inner diameter of the shaft and handle of the micro suturelasso¿, straight.No problem found.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is not confirmed; the reported item (ar-8703) was not returned, and an ar-8704 was received instead.One unpackaged ar-8704 micro suturelasso¿, tfcc, short, 70° bend was received for investigation.The reported failed device (ar-8703) was not returned for evaluation; according to the customer's information, the wrong device was mistakenly sent for evaluation.Upon visual inspection, the sutureless was returned inside the driver.No damage to the device was noted.Functional testing was performed four times and revealed that the suturelasso passed through the inner diameter of the shaft and handle of the micro suturelasso¿ straight.No problem found.

• Brand Name: MICRO SUTURELASSO, STRAIGHT
• 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: 18586385
• Report Number: 1220246-2024-00555
• Device Sequence Number: 8517412
• Product Code: LXH
• UDI-Device Identifier: 00888867044753
• UDI-Public: 00888867044753
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 04/16/2025

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: MICRO SUTURELASSO, STRAIGHT
• Device Catalogue Number: AR-8703
• Device Lot Number: 2306126598
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: Not provided; 03/31/2025
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 08/21/2024; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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