MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNOT MANIPULATOR QUICK-T; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7210116
Medical Device Problem Codes	Material Deformation (2976); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, the knot manipulator pusher cut the anchor wires when tightening the knot.The procedure was completed without surgical delay using the same device.No further complications were reported.
Additional Manufacturer Narrative
H10: 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.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the lot number laser etched into the device matches the complaint.Per the part drawings document, the front end of the shaft should have no sharp edges: must be smooth.It is tested with two sutures.There are no sharp edges or burrs on the returned device.It is smooth.There are no visible defects.A functional evaluation using a #2 suture showed that the device did not fray or cut the suture after multiple passes.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.An evaluation of the images provided by the customer found the device shows wear from use.There are no deformities visible.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4) h11 h6: medical device problem code and health effect - impact code updated.
Additional Manufacturer Narrative
H2: additional information in d4 and h4.

• Brand Name: KNOT MANIPULATOR QUICK-T
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 20988826
• Report Number: 1219602-2024-02851
• Device Sequence Number: 12906905
• Product Code: NBH
• UDI-Device Identifier: 03596010482563
• UDI-Public: 3596010482563
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2025

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: 7210116
• Device Lot Number: 51198806
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 07/16/2025; 07/31/2025; 08/08/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 07/17/2025; 07/31/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Female