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

Catalog Number 72202901

Device Problem Component Falling (1105)

Patient Problem No Information (3190)

Event Date 04/28/2017

Event Type  malfunction  

Event Description

It was reported the anchor fell into the cancellous bone while attempting to insert it.

Manufacturer Narrative

Device investigation narrative - visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

One 72202901 footprint ultra pk 4.5 mm suture anchor returned.The anchor was not returned.One green poly suture was returned and the stay suture attached to the suture threader.There were no clinical details provided such as size and method of tap or tunnel, patient bone quality.The device does not show signs of aggressive use.The shaft is straight.The distal inner tip is undamaged and spins concentrically.A functional evaluation was performed and the torque limiter functioned as intended.Audible click was heard with advancement.The complaint said ¿the anchor fell into the cancellous bone while attempting to insert it.¿ ¿warning: rotate the torque limiter counterclockwise only enough to allow the sutures to slide easily.Excessive counterclockwise rotation can unscrew the inner anchor plug from the anchor implant, possibly resulting in a damaged anchor or the inner plug falling off the inserter and into the joint.¿ after evaluation the root cause of this event was deemed to be user error.A review of the device history record was performed which confirmed no inconsistencies.

• 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 w. william cannon; austin, TX 78735
• MDR Report Key: 6700799
• MDR Text Key: 79776707
• Report Number: 1219602-2017-00747
• Device Sequence Number: 1
• Product Code: MBI
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 72202901
• Device Lot Number: 50651752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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