MAUDE Adverse Event Report: SMITH & NEPHEW, INC. QUADTRAC DISPOSABLE KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	72205580
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, when the quadtrac disposable kit was opened, the sterile packaging had already been opened and was missing almost all parts.As this was noticed upon inspection, there was no patient involvement.
Additional Manufacturer Narrative
Internal 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 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
H11: internal complaint reference (b)(4).H2: additional information: g4: 510k.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 images found the first image shows an identification label where the reported kit identification matches.The second image shows the tray open and empty.The reported failures related to non-sterile packaging and missing components could not be confirmed because the tray was unsealed.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 review of the manufacturing process found that the assembler must verify presence of all the components.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: QUADTRAC DISPOSABLE KIT
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• 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: 23320085
• Report Number: 1219602-2025-02581
• Device Sequence Number: 20043332
• Product Code: KDD
• UDI-Device Identifier: 00885556818282
• UDI-Public: 885556818282
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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 Expiration Date: 03/17/2026
• Device Catalogue Number: 72205580
• Device Lot Number: 2114536
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 03/17/2023
• 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