MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CURVED INCISOR PLUS ELITE BL 4.5MM; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200036
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: case (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it was not in its original packaging.The distal end of the inner shaft and the cutting surface are fractured away from the inner shaft and stuck in the outer shaft of the device.This finding is related to the reported event.There was biological debris on the returned items.A functional evaluation could not be performed because the damage to the device prevented testing.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 failures could not be determined.Factors that could have contributed to the failures include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (crushing, shear force or excessive force induced on the shaft or an impact event inconsistent with normal use).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 an arthroscopy, the curved incisor plus elite blade was making the oscillating sound as expected but was not turning the blade to resect the tissue.The procedure was finished with a smith and nephew back up device.There was no surgical delay and no further complications were reported.

• Brand Name: CURVED INCISOR PLUS ELITE BL 4.5MM
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20915928
• Report Number: 1219602-2024-02765
• Device Sequence Number: 8581645
• Product Code: HAB
• UDI-Device Identifier: 03596010555700
• UDI-Public: 03596010555700
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 12/12/2024

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: 72200036
• Device Lot Number: 51111726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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 Sex: Unknown