MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 4.0 EP-1 DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205324
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 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 risks with the device itself or with its use 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 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 a surgery, it was noticed that there were iron wires at the grinding area of the abrader blade, and the polishing was not done thoroughly, and could not be use.The procedure was resumed, with a non-significant delay, using an equivalent sn back up device.It is unknown if there was a delay.No further complications were reported.
Event or Problem Description
It was reported that, during a surgery, it was noticed that there were iron wires at the grinding area of the abrader blade, and the polishing was not done thoroughly, and could not be use (the grinding wires were noticed before the abrader was used in the patient.No pieces fell off inside the patient).The procedure was resumed, with a non-significant delay, using an equivalent sn back up device.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 h3: additional information received/reviewed by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the grinding wires were noted before the device was used in the patient and confirmed that it was not used due to the malfunction, therefore, event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable per applicable regulations.If additional details confirm the occurrence of a reportable event, we will update our records accordingly and submit a subsequent report detailing both the event and our completed investigations.

• Brand Name: ABRADER 4.0 EP-1 DSPL BLADE
• 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: 24054997
• Report Number: 1219602-2026-00138
• Device Sequence Number: 15923665
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 3596010251527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/21/2026

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: 7205324
• Device Lot Number: 51119705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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