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

Catalog Number	AR-6060-90
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional 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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation of the two returned devices revealed that the nitinol wires at the distal tips were broken-off.Complaints event is typically caused by use of excessive force and/or prying/leveraging with the tip fully exposed on the device during use.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 or Problem Description
It was reported that during a rotator cuff repair procedure, when the surgeon was retrieving a suture, the metal tip of the suturesnare broke off into the patient's soft tissue and was unable to be recovered.A second suturesnare was opened and used to complete the case and the tip of this one broke of as well.The tip of the second suture snare was retrieved and the case was completed.Patient is a male, 65.Follow-up investigation: an x-ray was not taken.The surgeon looked for the first tip but determined that it was in the soft tissue and could not be retrieved.The second tip was found and removed.There were no unplanned incisions.The case was completed by passing the sutures with a birdbeak to complete the pasta repair.

• Brand Name: SUTURESNARE, 90 STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7341112
• Report Number: 1220246-2018-00088
• Device Sequence Number: 1393843
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: 00888867204638
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2018

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: 05/01/2021
• Device Catalogue Number: AR-6060-90
• Device Lot Number: 10049036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/15/2018
• 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
• Patient Age: 65 YR