MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO 25° RIGHT; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

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	01/25/2023
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 a knee surgery the surgeon was not able to unwound the thread.The device is blocked on 1cm of thread.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.It was further reported that due to the change of the device the process needed to be changed.No further information were provided.30-jan-2023 update: further information were provided that the same issue occurred multiple times during one surgery with multiple devices.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon visual evaluation, it was noted that the returned device has no issues.No problem found.Functional testing noticed that the driver suture lasso works as required.

• Brand Name: SUTURELASSO 25° RIGHT
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16361808
• Report Number: 1220246-2023-06283
• Device Sequence Number: 7259390
• 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): 10/04/2023

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: 2182123199
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown