MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM SER 3000; SAW, POWERED, AND ACCESSORIES

Catalog Number	7206010
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference number: (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 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 scope with a sad procedure, metal debridement was seen in the joint after using the 5.5mm full radius blade.The metal debris was suspected to have originated from the blade while it was shaving hard bone.The metal debris were removed from inside the patient using the 4.5 bonecutter on oscillate mode.The procedure was completed with a s+n back up device.There was a surgical delay of 1-2 minutes and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference case-(b)(4).H3, h6: the reported device was received for evaluation with another device.A visual evaluation showed that they were received together without original packaging and no identification of lot numbers.The color scheme of the devices matches the print.Both inner blades have scoring in multiple locations from debris.Bio debris present.A functional testing found the inner blade rotated freely inside the outer blade when spun by hand.A spin test was performed on each blade manually, no suction or irrigation, over a black mat.A single miniscule metal shaving, verified with a scope, was produced.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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (insufficient irrigation or an application of unintended inappropriate or excessive force to the device).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FULL RADIUS BLADE 5.5MM SER 3000
• 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: 22166896
• Report Number: 1219602-2025-01393
• Device Sequence Number: 12717318
• Product Code: HAB
• UDI-Device Identifier: 03596010440235
• UDI-Public: 3596010440235
• 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): 06/15/2026

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: 7206010
• Device Lot Number: 51286869
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2025
• 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