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

Model Number 7210116

Device Problem Sharp Edges (4013)

Patient Problem No Information (3190)

Event Date 10/06/2020

Event Type  Injury  

Event Description

It was reported that during surgery the knot manipulator was cutting the suture intraoperative; there is no information regarding how the procedure was completed nor if there was any delay.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection using a digital microscope confirmed the distal tip edge was not smooth.There are some edges that could fray or cut suture with enough force.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of the instructions for use found: it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges the complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: KNOT MANIPULATOR QUICK-T
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10770776
• MDR Text Key: 214119550
• Report Number: 1219602-2020-01740
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010482563
• UDI-Public: 03596010482563
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 7210116
• Device Catalogue Number: 7210116
• Device Lot Number: 50870295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention