MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL 4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Model Number	7210499
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the label of the box had a problem.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found the label in question is fraudulent.This label was not printed from any s+n global labeling controlled systems.A labeling expert certified multiple inconsistencies.The customer provided image and video display the fraudulent label.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 complaint history review concluded this was an isolated event.A review of the packaging specification found the carton label is product specific to the bill of materials.The complaint was confirmed and the root cause was associated with a falsified device.No containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE BL 4.5MM FR ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10518145
• Report Number: 1219602-2020-01387
• Device Sequence Number: 2445329
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 50759079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1