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

Model Number 72205292

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11440988
• MDR Text Key: 238583212
• Report Number: 1219602-2021-00455
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885556764473
• UDI-Public: 00885556764473
• 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
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1