MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210979
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified procedure, metal came off the blade 4.5 bonecutter.Surgery was completed using a back-up device instead.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with original packaging.The color and magnet scheme of the device matches the print.There is minimal light scoring on a single area of the inner blade.There are some light impact marks on the edges of the inner blade cannula window.A specimen bottle was returned with the blade, but no metal particles were located within it.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 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.The root cause has been associated with a component failure.Factors that could have contributed to the failure include insufficient irrigation during use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BLADE,4.5 BONECUTTER,FR,180MM LG,DSP
• 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: 22802282
• Report Number: 1219602-2025-02018
• Device Sequence Number: 15403201
• Product Code: HAB
• UDI-Device Identifier: 03596010544001
• UDI-Public: 3596010544001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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 Expiration Date: 10/05/2026
• Device Catalogue Number: 7210979
• Device Lot Number: 50970175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 09/19/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/19/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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