MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER 5.5MM PLATINUM; ARTHROSCOPE

Catalog Number	72202530
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery, metal debris from the 5.5 mm bonecutter platinum was coming off inside the patient¿s joint; it is unknown if there was a backup device available or if there was a surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 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
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.An analysis of the customer provided image shows the product information of the reported device.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 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 based on the information provided, the definitive clinical root cause of the reported adverse event could not be determined.The ifu for the dyonics arthroscopic blades does caution that ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.No further complications were reported.Nor has it been reported whether the metal debris was removed from inside of the patient¿s joint.Therefore, the impact to the patient beyond possibility of infection, corrosion, local irritation/discomfort, and/or migration of the possible retained metal debris cannot be determined.Factors that can contribute to the reported event include excessive ¿side-loading¿ on the blade during use may, in extreme cases, result in wear and degradation of the inner blade.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 5.5MM PLATINUM
• Common Device Name: ARTHROSCOPE
• 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: 22323057
• Report Number: 1219602-2025-01598
• Device Sequence Number: 8830136
• Product Code: HRX
• UDI-Device Identifier: 03596010655684
• UDI-Public: 3596010655684
• 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): 07/28/2025

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: 72202530
• Device Lot Number: 51259980
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/28/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown