MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 45 DEGREE, CURVE LEFT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURELASSO, 45 DEGREE, CURVE LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On the (b)(6) 2023, it was reported via email that an ar-4068-45l suturelasso had an issue.The device snapped off inside of the patient's shoulder during surgery while trying to bring device back through the port as per procedure needs.There was a case and patient involved.The tip was able to be located and retrieved so no adverse effect for patient occurred.
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
The complaint allegation is confirmed.Per the event description, "on the 13th of march 2023 it was reported via email that an ar-4068-45l suturelasso had an issue where the device snapped off inside of the patient's shoulder during surgery while trying to bring device back through the port as per procedure needs.It is concluded that the tip of the suturelasso¿ sd, 45° curve left, was broken off when it was trying to be removed.No pictures provided.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: SUTURELASSO, 45 DEGREE, CURVE LEFT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 16713943
• Report Number: 1220246-2023-06505
• Device Sequence Number: 17935086
• Product Code: LXH
• UDI-Device Identifier: 00888867031470
• UDI-Public: 00888867031470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Expiration Date: 02/28/2025
• Device Model Number: SUTURELASSO, 45 DEGREE, CURVE LEFT
• Device Catalogue Number: AR-4068-45L
• Device Lot Number: 0066101852
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown