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

Model Number 72202468

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/03/2018

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2018, in the meniscal suturing operation at the (b)(6), the second hit, the line did not come out.No patient injury or significant time delay reported.

Manufacturer Narrative

One 72202468 fast-fix 360 curved needle delivery system device returned.Complaint stated: ¿the second hit, the line did not come out.¿ the device is in very poor condition.The depth limiter is attached.T1, t2 and suture were not returned.The delivery needle is disfigured.It is bowed, bent and twisted.The damage attained impedes the functional test.This device no longer cycles or actuates.The physical condition is indicative of a challenge to reach the desired surgical location.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Type of Device: STAPLE, FIXATION, BONE
• 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: 7436283
• MDR Text Key: 105847117
• Report Number: 1219602-2018-00442
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00885554023077
• UDI-Public: (01)00885554023077(17)200714(10)50674677
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• 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
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: 72202468
• Device Catalogue Number: 72202468
• Device Lot Number: 50674677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• 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