MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER 4.5MM PLATINUM; SAW, POWERED, AND ACCESSORIES

Catalog Number	72202531
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 a shoulder arthroscopy, the six(6) full radius bonecutter blades of the same box produced a metallic powder.As a result, the residual metallic particles were left in the patient's body, and the surgeon removed as much as possible.The procedure was resumed, with a delay greater than 30 minutes, using an equivalent sn back-up.Additional anesthesia was required as a consequence of the surgical prolongation.No further complications were reported.
Event or Problem Description
It was reported that, during a shoulder arthroscopy, one blade of the box full radius bonecutter blade produced a metallic powder.As a result, the residual metallic particles were left in the patient's body, and the surgeon removed as much as possible by suction; however, it is not entirely certain that they were completely removed.The procedure was resumed, with a delay greater than 30 minutes.The issue occurred near the end of the surgery; therefore, the same device was used to complete the procedure.Additional anesthesia was required as a consequence of the surgical prolongation.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Additional information: correction: h6 (health effect - impact code) f24 was removed.
Additional Manufacturer Narrative
H2: corrected information in h6 (component code & investigation findings).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 clinical review states that intraoperative photos were provided for review and confirm the reported, however they do not indicate a root cause.Based on the information provided the clinical root cause for the report event could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event.It is unclear if the device ifu was adhered to.The patient impact was determined to be the prolong procedure.If any shavings were retained within the patient micro-motion or movement cannot be predicted.There would also be potential risk for tissue inflammation and/or pain.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.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual evaluation showed one box/six devices were returned with the batch number of the complaint on the label.Five blades were sealed/unopened and one blade was opened.The color and magnet scheme of the devices matches the print.The inner blade shows some light scoring on the distal end.Bio debris is present.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 clinical review states that intraoperative photos were provided for review and confirm the reported, however they do not indicate a root cause.Based on the information provided the clinical root cause for the report event could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event.It is unclear if the device ifu was adhered to.The patient impact was determined to be the prolong procedure.If any shavings were retained within the patient micro-motion or movement cannot be predicted.There would also be potential risk for tissue inflammation and/or pain.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.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.

• Brand Name: FULL RADIUS BONECUTTER 4.5MM PLATINUM
• 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: 23556765
• Report Number: 1219602-2025-02857
• Device Sequence Number: 21273291
• Product Code: HAB
• UDI-Device Identifier: 00885554027891
• UDI-Public: 885554027891
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/12/2026

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: 72202531
• Device Lot Number: 51259972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/22/2025; 03/10/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/23/2025; 03/12/2026
• 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