MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMOOTHER TOOL 9.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	014724
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an anterior cruciate ligament surgery, circulation nurse made the doctor aware that the "9.5mm acufex smoother tool" was expired and physician chose to use the expired product.The product was opened by persons other than a s+n employee.The procedure was finished with the same device with no delay.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/isdtructions 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.

• Brand Name: SMOOTHER TOOL 9.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10261832
• Report Number: 3003604053-2020-00062
• Device Sequence Number: 3853761
• Product Code: NBH
• UDI-Device Identifier: 03596010026262
• UDI-Public: 03596010026262
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 014724
• Device Catalogue Number: 014724
• Device Lot Number: 020217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/11/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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