MAUDE Adverse Event Report: MEDLINE RENEWAL; ARTHREX SUTURELASSO¿ SD, 25 DEGREE TIGHT CURVE LEFT, WIRE LOOP, (GREEN) 1.8MM

Catalog Number AR4068251RH

Device Problems Component Falling (1105); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during an unknown procedure, while threading the wire for the arthrex suture lasso, the wax coating on the wire scrapped off and fell into surgical site.Reportedly, a grasper was used to retrieve the wire residues from the surgical site; however, it was not sure whether all pieces were retrieved.General anesthesia was used and per report, the procedure was extended 25 minutes due to the reported incident.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.The sample was not returned for evaluation.A root cause has not been determined at this time.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that while threading the wire for the arthrex suture lasso, the wax coating on the wire scrapped off and fell into surgical site.

• Type of Device: ARTHREX SUTURELASSO¿ SD, 25 DEGREE TIGHT CURVE LEFT, WIRE LOOP, (GREEN) 1.8MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 7580179
• MDR Text Key: 110464965
• Report Number: 3032391-2018-00004
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: AR4068251RH
• Device Lot Number: 341218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention