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

Model Number	SUTURELASSO, CRESCENT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation of the returned ar-4068c revealed that the crescent tip of the suture lasso had broken off prior to receipt for investigation.Complainant's event is most likely caused by leveraging the device against hard bone or another instrument.
Event or Problem Description
It was reported that, while piercing through the labrum with the ar-4068c in a shoulder labral repair procedure, the tip of the suture lasso broke off in the labrum near the base of the biceps.This occurred while the surgeon was attempting to pass the last suture.The surgeon made an additional portal and was able to efficiently and fully remove the broken piece.The procedure was completed, and an additional surgery is not required.This occurred during the initial/first time use of the device.

• Brand Name: SUTURELASSO, CRESCENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7994467
• Report Number: 1220246-2018-00709
• Device Sequence Number: 428369
• Product Code: LXH
• UDI-Device Identifier: 00888867031555
• UDI-Public: 00888867031555
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: SUTURELASSO, CRESCENT
• Device Catalogue Number: AR-4068C
• Device Lot Number: 817184338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other