MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMOOTHER TOOL 7.9MM; ACCESSORIES,ARTHROSCOPIC

Model Number 014723

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/18/2020

Event Type  Injury  

Event Description

It was reported that during a reconstruction of lcp, the smoother stalled in the tunnels and when it was being trying to remove it, the plastic part of traction was broken.The pieces were removed from the patient with pliers.The procedure was successfully completed with a significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3, h6: the device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no other related failures.All risks have been adequately identified and no changes are required at this time.A device labeling/nstructions for use review was performed and indicated the instructions for use includes recommendations, instructions and precautionary statements for proper use of the product.Factors that are known to contribute to the alleged fault/failure may include shipping damage or excessive force.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.

Manufacturer Narrative

The device, which was used in a procedure, was returned for evaluation.A relationship between the device and the reported incident was confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no other related failures.All risks have been adequately identified and no changes are required at this time.A device labeling/ifu review was performed and indicated the instructions for use includes recommendations, instructions and precautionary statements for proper use of the product.A visual inspection found the plastic portion of the smoother product to have tears throughout and found the metal wire to be torn and frayed at both the distal and proximal end of the device.A review of the customer provided images found the images to display damage to the device.The damages displayed in the images were observed in the visual inspection of the returned device.The complaint was confirmed.Factors may have contributed to the incident include excessive force.

• Brand Name: SMOOTHER TOOL 7.9MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10262201
• MDR Text Key: 198487859
• Report Number: 3003604053-2020-00066
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010026255
• UDI-Public: 03596010026255
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 014723
• Device Catalogue Number: 014723
• Device Lot Number: 2041860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/12/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 10/12/2021
• Supplement Dates FDA Received: 08/31/2020; 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention