MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 CURVED NDL DELIVERY SYS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72202468

Device Problem Firing Problem (4011)

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

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that during a meniscal repair surgery, a fast fix´s t2 deployed simultaneously with the t1 implant.Surgery resumed with a back-up device however it´s unknown if there was any delay.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual evaluation of the device showed it was returned in the original box with the batch number of the complaint on the label.The t1/t2/suture were returned off the needle.The knot has been tightened down.The actuator is in the pre-t2 position.A functional evaluation showed the device cycled as intended.An evaluation of the customer provided image shows the device laying beside a s+n box.The t1/t2/suture are off the needle and laying beside the device.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 found similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that may have contributed to the reported event include inadvertently bending of the needle/overmold assembly or excessive retraction of the device causing t2 to be pulled from the needle.No containment or corrective actions are recommended at this time.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 15397359
• MDR Text Key: 299659858
• Report Number: 1219602-2022-01343
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554023077
• UDI-Public: 00885554023077
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202468
• Device Catalogue Number: 72202468
• Device Lot Number: 2080917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other