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

Catalog Number	72200036
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an arthroscopic right shoulder stabilization, after 30 seconds of debriding soft tissue, particularly the labrum, metal shavings from the curved incisor blade were observed in the glenohumeral joint space.A straight 4.5 shaver was opened to remove all the shavings from the patient.The surgery was completed using a smith and nephew back-up device instead.There was a surgical delay of less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H2: corrected information in h6 (investigation findings).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging.The color scheme of the device matches the print.Bio debris is present.No metal shavings or flakes are visible.There are no other visible defects.A functional evaluation was performed on the returned device and found that when connected to a reference mdu, it spins as intended without grinding, seizing, or unexpected noise.No metal flakes were observed during testing.However, a clinical review states that an arthroscopic image was provided that confirms the presence of metal shavings in the glenohumeral joint space.Based on the information provided, a procedural variance could not be ruled out of the reported adverse event.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 insufficient irrigation during use or unintended excessive force and side loading of the device.Based on this investigation, the need for corrective action is not indicated.

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22121510
• Report Number: 1219602-2025-01329
• Device Sequence Number: 14480634
• Product Code: HAB
• UDI-Device Identifier: 03596010555700
• UDI-Public: 3596010555700
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/18/2025

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: 72200036
• Device Lot Number: 51103596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2023
• 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 Age: 24 YR
• Patient Sex: Female