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

Catalog Number	72205292
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that it was not returned with original packaging.The color and magnet scheme of the device matches the print.The inner blade is deformed and fractured from contact with another metal object.The torn/fractured pieces of metal are twisted and bent back into the blade.A functional evaluation was performed on the returned device and found that the inner blade cannot spin due to the torn/fractured pieces of metal that are bent back into the blade and blocking the rotation space.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 found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (contact with another metal object or excessive force).Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported during an unspecified procedure, it was noticed that the 4.0mm platinum flyer blade's jaw was defective as the blades did not fit and rotate smoothly into each other.It is unknown how the procedure was performed or if there was a surgical delay.No further complications were reported.Results of investigation concluded that the inner blade is deformed and fractured.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24248750
• Report Number: 1219602-2026-00308
• Device Sequence Number: 8309580
• Product Code: HAB
• UDI-Device Identifier: 00885556764473
• UDI-Public: 885556764473
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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 Catalogue Number: 72205292
• Device Lot Number: 51260005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown