MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202901

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

It was reported that anchor fell out.No significant delay or patient injury reported.

Manufacturer Narrative

One 4.5 footprint ultra pk suture anchor assembly was returned for evaluation.Inserter and anchor were returned, no stay suture.The anchor is soiled with human matter.Visual assessment of the anchor showed the anchor remains attached to the inserter.Inserter was functionally tested and the inner plug moved within the anchor as intended.The anchor is easily removed from the inserter.This investigation could not identify any evidence of product contribution to the reported complaint.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

One fast-fix 360 curved needle delivery system was returned for evaluation.Visual assessment of the device showed the actuator is in its post t2 deployment position indicating a complete deployment.No ts or sutures remain on the insertion needle, however a 12 inch length of suture was returned.Examination of the suture found no abnormalities; its length is consistent with a successfully used device.The device was functionally tested for proper actuator advancement and cycling and was found to function as intended.It appears that the trigger was inadvertently advanced causing the pre-deployment of t2.Per the device ifu under warnings ¿do not push the deployment slider twice or the second implant will deploy prematurely¿.No root cause related to the manufacture of the device can be established.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 7040352
• MDR Text Key: 92973875
• Report Number: 1219602-2017-01433
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: (01)03596010650528(17)210725(10)50612828
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: 50612828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• 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
• Patient Age: 55 YR