MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLUSH SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC

Model Number 72203053

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

It was reported that the flush suture cutter had jaw issues, it did not open.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows some wear from use.There is a small area of blue debris about halfway down the shaft.There is some deformation of the outer shaft at the distal end.A functional assessment of the device found the device opens and closes with difficulty and will not cut cleanly through test suture material.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include maintenance issues, excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: FLUSH SUTURE CUTTER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10694710
• MDR Text Key: 211875901
• Report Number: 1219602-2020-01602
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010653666
• UDI-Public: 03596010653666
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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 Model Number: 72203053
• Device Catalogue Number: 72203053
• Device Lot Number: 50819075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/18/2020
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1