MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 90 DEGREE STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO, 90 DEGREE STRAIGHT
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	11/28/2022
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 the shoulder arthroscopy the lasso was already frayed and then it tear off.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
Complaint is confirmed.One unpackaged ar-4068-90 suturelasso¿ sd, 90° straight serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the broken wire.Visual evaluation found that the nitinol wire loop was broken before received the device for evaluation.The cause remains undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: SUTURELASSO, 90 DEGREE STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15964532
• Report Number: 1220246-2022-05923
• Device Sequence Number: 20071617
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: 00888867031517
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/23/2023

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, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Device Lot Number: 2025118939
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown