MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO SD, 30 DEG STRAIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO SD, 30 DEG STRAIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
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 bankart surgery, the lasso broke inside the patient's shoulder.There was no reported 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.20-sep-2023 update dw further information was provided that the broken pieces were removed by the surgeon.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Upon visual evaluation, it was noted that the distal tip, 30° straight, suturelasso of the returned suturelasso¿ sd, 30° straight was broken.No broken piece was returned for investigation.The most likely cause of this condition is use error related to excessive force used to pry and leverage the device.Functional testing was not performed due to the damage to the device.

• Brand Name: SUTURELASSO SD, 30 DEG STRAIGHT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17930960
• Report Number: 1220246-2023-08190
• Device Sequence Number: 20451144
• Product Code: LXH
• UDI-Device Identifier: 00888867031463
• UDI-Public: 00888867031463
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/14/2024

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 SD, 30 DEG STRAIGHT
• Device Catalogue Number: AR-4068-30
• Device Lot Number: 3146132029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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