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

Model Number	SUTURELASSO 25° RIGHT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl repair surgery the wire winded in the rollers and did not came out of the end.There was no harm for patient, operator or third party.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-6068-25r batch, 3174132712, was received for evaluation.Visual evaluation noted marks on the wheel grip lasso equivalent to excessive pressure trying to pass the suture through the wheels; an obstruction was noted on the tip of the shaft, possibly fluid or other contamination.Functional testing with an ar-7222 batch 30084 found resistance when the suture was introduced slowly, and the wheel moved softly without pressure.The suture did not pass.The most likely cause of the reported event is a user error following the device's surgical technique.

• Brand Name: SUTURELASSO 25° 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: 20124989
• Report Number: 1220246-2024-07335
• Device Sequence Number: 14269331
• Product Code: GAT
• UDI-Device Identifier: 00888867247512
• UDI-Public: 00888867247512
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122374
• 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): 01/03/2025

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: SUTURELASSO 25° RIGHT
• Device Catalogue Number: AR-6068-25R
• Device Lot Number: 3174132712
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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