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

Catalog Number	72203521
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a knee scope, the blade was leaving a metal material in the joint.Surgery was completed with a smith and nephew back-up device instead.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not received for evaluation.However, another twenty seven devices were received unopened/sealed in original packaging with the batch number of the complaint on the label.A visual inspection of these devices revealed the color scheme of the devices matches the print.Through the tray, a scratch or scoring can be seen on some of the outer distal blades.After opening five sample devices and separating the inner from outer blades, scoring is present on the distal end, of the inner blade, of all five samples.There is also a substance covering parts of the distal end which is consistent with surillium coating.Scoring or abrasions are also present on the proximal end of four of the five samples.A functional evaluation was performed and found the inner blade rotated freely inside the outer blade when spun by hand.A spin test 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.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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 review of the form, fill and seal packaging sequence found that the operator should make inspections for product presence, printing defects and particulate before continue to final package the trays.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include an application of unintended inappropriate or excessive force to the device.Based on this investigation, the scratches/scoring found are considered potential signs of rough handling or storage.Additionally the surillium coating found is a substances used during our manufacturing process to help prevent shedding and improve lubricity.The presence of the sirillium does not represent a potential risk either a manufacturing issue.Therefore 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 evaluation.

• Brand Name: 4.5MM FULL RADIUS PLATINUM SERIES
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20627433
• Report Number: 1219602-2024-02481
• Device Sequence Number: 8820476
• Product Code: HAB
• UDI-Device Identifier: 00885554024333
• UDI-Public: 885554024333
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72203521
• Device Lot Number: 51225715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown