MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 rotator cuff arthroscopy it was not possible to pull the wire loop with the suture retriever, as the wire loop of the device immediately tore inside the patient.No part of the device broke off inside the patient.There was no harm or adverse event for patient, operator or third party reported.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 confirmed.Visual inspection identified breakage to the suturelasso wire at the loop.No damage was noted to the curved tip of the suturelasso assembly, and no other abnormalities were identified.During device functioning, the wire was able to move as intended.The cause of this event is undetermined; however, most likely caused are the application of prying/leveraging forces to the device during use and/or interference with sharp instruments.

• Brand Name: SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12198254
• Report Number: 1220246-2021-03413
• Device Sequence Number: 12073327
• Product Code: LXH
• UDI-Device Identifier: 00888867031425
• UDI-Public: 00888867031425
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 10/31/2024
• Device Model Number: SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
• Device Catalogue Number: AR-4068-25TL
• Device Lot Number: 929598241
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1