MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210909
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Material Twisted/Bent (2981); Scratched Material (3020); Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference case-(b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it was not returned with original packaging.The color scheme of the device matches the print.One tooth of the inner blade has bent out of position and is missing the upper portion of the tooth.There is heavy scoring inside the outer blade and deformed on the opening edges from the deformed inner blade rotating inside of it.A functional evaluation was performed on the returned device and found that it is not possible to manually rotate the inner blade, nor can it be removed from the outer blade due to the bent tooth.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found a similar reported event.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 allowing the rotating portion of the blade to touch another metal object or excessive ¿side-loading¿.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a meniscectomy, the disposable blade stopped working, and when it was removed from the handpiece, the tip was getting stuck when turning.The procedure was completed without any surgical delay using a s+n back-up device.No further complications were reported.

• Brand Name: BLADE 5.5 FULL RADIUS ELITE DISPOSABLE
• 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: 22039725
• Report Number: 1219602-2025-01168
• Device Sequence Number: 8899115
• Product Code: HAB
• UDI-Device Identifier: 03596010582737
• UDI-Public: 3596010582737
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 7210909
• Device Lot Number: 51185330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 12/07/2023
• 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 Age: 18 YR
• Patient Sex: Female