MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHEX; AR-4068-25TL @SUTLASSO SD, 25 DEGREE TIG

Catalog Number AR406825TRH

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Detailed description of the event: it was reported that shavings of the arthex suturelasso sd had to be irrigated out of the patient.According to the customer, while the surgeon was repairing a rotator cuff, the reprocessed suture lasso broke.Reportedly, the reprocessed shaver left metal flakes in the patient's shoulder, during the arthroscopy procedure.Due to the need for medical intervention and in an abundance of caution, this is an mdr reportable event.No additional information is available at this time.If additional information becomes available, this report will be re-opened and re-evaluated.

Event Description

It was reported that shavings of the arthex suturelasso sd had to be irrigated out of the patient.

• Brand Name: ARTHEX
• Type of Device: AR-4068-25TL @SUTLASSO SD, 25 DEGREE TIG
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond, or
• Manufacturer Contact: kathy woods ; three lakes drive; northfield, il ; 9317708
• MDR Report Key: 10135879
• MDR Text Key: 202222374
• Report Number: 3032391-2020-00004
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: AR406825TRH
• Device Lot Number: 413844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/09/2020
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention