MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM PLATINUM FLYER BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	72205292
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that an unusual packaging was noticed for a platinum flyer blade.Upon further inspection it was realized that sterile seal was compromised.No case reported; therefore, there was no patient involvement.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 reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Two devices from lot number 50903212 were returned for evaluation.A visual inspection found the sterile barrier on both devices were breached and the inner side of tyvek packaging had blue print.The thermoformed number on the clear plastic tray of the first device was a 2, however the second devices was a 4.Analysis of the customer provided images confirmed blue print on the inner side of the tyvek packaging.The sterile barrier was compromised.The thermoformed number on the clear plastic tray of the first device was a 2, however the second devices was a 4.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 a repeat issue.A review of the visual inspection and seal machinery process summaries confirmed the device is inspected for comprised seal integrity and abnormalities.The complaint was confirmed and the root cause was associated with manufacturing.A complaint notification has been issued to manufacturing management to mitigate future recurrences.

• Brand Name: 4.0MM PLATINUM FLYER BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11440988
• Report Number: 1219602-2021-00455
• Device Sequence Number: 16984142
• Product Code: HAB
• UDI-Device Identifier: 00885556764473
• UDI-Public: 00885556764473
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 11/01/2025
• Device Model Number: 72205292
• Device Catalogue Number: 72205292
• Device Lot Number: 50903212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1