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

Model Number	014723
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10262201
• Report Number: 3003604053-2020-00066
• Device Sequence Number: 3462841
• Product Code: NBH
• UDI-Device Identifier: 03596010026255
• UDI-Public: 03596010026255
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/28/2020; 10/12/2021
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 08/31/2020; 10/13/2021
• 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: Required Intervention