MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 CURVED NDL DELIVERY SYS; PASSER

Model Number 72202468

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

It was reported that t1 and t2 deploy together.

Manufacturer Narrative

This device shows attempted use.T1, t2 and suture were returned separated from the delivery needle.The anchors have been cinched in closer proximity to each other than their original manufacturing locations.Suture has been knotted and cinched around t1 lengthwise.This symptom would encourage t1 to pull back through meniscus tissue.T1 had bio-matter attached and has a curved condition which is a symptom of being pulled back through tissue after anchoring.The depth limiter was attached and had been retracted one increment.There is no apparent twisting or bending of the delivery needle although the delivery curve was somewhat flattened.If the delivery needle has been inadvertently bent, or if resistance is encountered during deployment, a new delivery device may be needed.A functional test confirmed that the device delivery system still cycled and actuated.No root cause related to the manufacture of the device was established.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7542492
• MDR Text Key: 109285750
• Report Number: 1219602-2018-00648
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885554023077
• UDI-Public: (01)00885554023077(17)201026(10)50693309
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Model Number: 72202468
• Device Catalogue Number: 72202468
• Device Lot Number: 50693309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1