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

Model Number SUTURELASSO, 90 DEGREE STRAIGHT

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Swelling (2091); Device Embedded In Tissue or Plaque (3165)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device disposition was unknown by reporter.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported during a primary shoulder arthroscopy labral repair procedure, as the surgeon went to pass the suture, the tip of the ar-4068-90 suturelasso broke off.The rep stated the surgeon spent approximately 90 minutes trying to retrieve the broken tip but was unable to remove the fragment due to severe swelling.This unretrieved fragment was reported under case (b)(4).The surgeon closed the patient and scheduled a second surgery to remove the broken fragment and to complete the repair.The original procedure took place on (b)(6) 2019.The second surgery took place at a different facility on (b)(6) 2019 and was performed by the same surgeon.The surgeon was able to fully remove the broken fragment by using a hip arthroscopy grasper.The repair was completed without further issue.

• Brand Name: SUTURELASSO, 90 DEGREE STRAIGHT
• Type of Device: 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: 8603643
• MDR Text Key: 144828127
• Report Number: 1220246-2019-01094
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: 00888867031517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: SUTURELASSO, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Device Lot Number: 901689838
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other