MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 4.0MM ABRADER 180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200080
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, was running the burr on forward mode and metal debridements were seen in the joint after this.All metal was retrieved through the oscillate mode.The procedure was successfully completed without surgical delay using a smith and nephew back up device.No further complications were reported.
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 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.
Additional Manufacturer Narrative
H11: h2: corrected information on: b5.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.The inner and outer blades show very minimal use and no wear.There is some bio debris but no visible defect.A functional testing was performed utilizing a reference control unit and mdu in saline solution.The blade was agitated in the solution and tapped lightly against the side of the glass beaker during the spin test.No shedding or particles were noted.The blade spins as intended without grinding, seizing, or unexpected noise.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 could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a procedure, when running the burr on forward mode, metal debridement were seen in the joint.All metal was retrieved through the oscillate mode.The procedure was successfully completed without surgical delay using a smith and nephew back up device.No further complications were reported.

• Brand Name: BURR 4.0MM ABRADER 180MML DISPOSABLE (3
• 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: 22738994
• Report Number: 1219602-2025-01960
• Device Sequence Number: 7189196
• Product Code: HAB
• UDI-Device Identifier: 03596010541512
• UDI-Public: 3596010541512
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 72200080
• Device Lot Number: 51301745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2025
• 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