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 05/24/2018

Event Type  malfunction  

Event Description

It was reported that t1 and t2 deploy together.

Manufacturer Narrative

One 72202468 fast-fix 360 curved needle delivery system device received.T1, t2 and suture were not returned.The depth limiter was attached.It is creased and flared.The symptoms are indicative of difficulty with reaching the desired anchoring location.The delivery needle curve has become somewhat flattened.There is not currently obvious bow or bend although temporary flexing is a cause of unintentional ancho release.A functional test confirmed that the device delivery system did cycle and actuate.No root cause related to the manufacture of the device was confirmed.

• 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: 7542830
• MDR Text Key: 109285801
• Report Number: 1219602-2018-00649
• 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: 07/20/2018

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?: No
• Date Device Manufactured: 10/26/2017
• 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