MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200081
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with any original packaging.One tooth on the outer blade was deformed and had shed fragments which caught between the blades as they rotated.The shavings from the tooth also scored the inside of the outer blade causing more metal to shed off.Bio debris was present.A functional evaluation was performed on the returned device and found the blades do not turn smoothly due to the metal shavings and bio debris caught in the teeth and between the blades.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.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 (insufficient irrigation or lack of irrigation, excessive force or an impact event to the device inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during for an arthroscopy, the inner components on the incisor plus elite blade were tightly inserted and they were almost impossible to remove.The blade couldn't be inserted, as it didn't rotate clockwise or counterclockwise, nor did it rotate in oscillation mode.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.

• Brand Name: INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX
• 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: 22538982
• Report Number: 1219602-2025-01787
• Device Sequence Number: 18010769
• Product Code: HAB
• UDI-Device Identifier: 03596010555687
• UDI-Public: 3596010555687
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/17/2025

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: 72200081
• Device Lot Number: 51259952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/17/2025
• 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