MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4KO ARTHROSCOPE DV AC 4X45DEGREE X160MM

Catalog Number	72205156
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Material Twisted/Bent (2981); Optical Obstruction (3002); Scratched Material (3020)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(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 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 after an arcr procedure performed on (b)(6) 2025, in which a 4ko arthroscope was involved x-rays revealed a wire-like piece of metal inside the patient's body.An additional surgery was performed on (b)(6) 2025 to remove the metal piece.Later upon revision it was found that the tip of the scope was damaged.The patient outcome is unknown.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection of returned device found the needle was bent, distal tip and fiber damage, distal lens scratched, keel missing, particulates, cracked negative lens.The reported malfunction was duplicated during functional testing.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 clinical review states that the 4ko arthroscopic x-ray image provided confirmed the wire-like metal piece was retained inside the patient's joint.The two videos were reviewed; however, they failed to upload.Therefore, an image from the initial video was taken that shows the damaged scope.Additionally, an image of the 2nd video was taken that shows a piece of wire like metal next to a rule measuring approximately 1cm.A third photo was of a wire-like piece of metal.Four photos were provided, one photo showed the part number visible on the scope, and other three photos revealed the damage to the tip of the scope.However, the removed wire-like piece of metal cannot be confirmed as part of the damaged tip of the scope.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The root cause was associated with a component failure.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: 4KO ARTHROSCOPE DV AC 4X45DEGREE X160MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21532150
• Report Number: 3003604053-2025-00007
• Device Sequence Number: 15466327
• Product Code: HRX
• UDI-Device Identifier: 00885556736098
• UDI-Public: 885556736098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 72205156
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown