MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 KPSC AND SLOTTED CANNULA; ACCESSORIES,ARTHROSCOPIC

Model Number 72202674

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an arthroscopy using two fast-fix 360, when the knot pusher/suture cutter was used, it did not cut the suture.The procedure was successfully completed without delay using a the same device, by forcibly pulling and cutting the suture.No patient injury or other complications were reported.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The instructions for use was 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 review of risk management files found that the reported failure was documented appropriately.A visual inspection revealed the device was returned outside of original packaging.No physical damage visible to device.A functional evaluation revealed the device cut suture as intended.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: FAST-FIX 360 KPSC AND SLOTTED CANNULA
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12196011
• MDR Text Key: 262423362
• Report Number: 1219602-2021-01592
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554023169
• UDI-Public: 00885554023169
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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: 72202674
• Device Catalogue Number: 72202674
• Device Lot Number: 2056337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention