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

Model Number	SUTURELASSO 25° LEFT
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	Serious Injury
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.
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 info: complaint is confirmed.Upon visual evaluation, it was noted that the returned suture was stuck between the wheels.Function test reveals that the wheels work as required.The most likely cause is excessive force/friction during use or insertion.

• Brand Name: SUTURELASSO 25° LEFT
• 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: 16361785
• Report Number: 1220246-2023-06276
• Device Sequence Number: 7258948
• Product Code: GAT
• UDI-Device Identifier: 00888867247505
• UDI-Public: 00888867247505
• 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): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: SUTURELASSO 25° LEFT
• Device Catalogue Number: AR-6068-25L
• Device Lot Number: 0287107073
• 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: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown