MAUDE Adverse Event Report: ARTHREX INC. SUTURELASSO, CRESCENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number AR-4068C

Device Problems Bent (1059); Break (1069)

Patient Problem No Information (3190)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Lot number was not provided so device history record review cannot be performed.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that during a shoulder arthroscopy case, after the crescent suturelasso, ar-4068c, had been bent multiple times by the surgeon, the tip broke off in the glenohumeral joint of the patient and needed to be retrieved.The broken piece of the suturelasso was approximately an inch long.The surgeon attempted to retrieve the piece using fluoroscopy during the original surgery but was unable to retrieve the piece arthroscopically.A second surgery was scheduled at a different hospital the same day for the removal of the suturelasso fragment by the same surgeon.It was confirmed that the second surgery took place and the suturelasso fragment was retrieved.

• Brand Name: SUTURELASSO, CRESCENT
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7600209
• MDR Text Key: 111006585
• Report Number: 1220246-2018-00242
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867031555
• UDI-Public: 00888867031555
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-4068C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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