MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202902

Device Problems Break (1069); Failure to Disconnect (2541)

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

Event Date 04/10/2017

Event Type  malfunction  

Event Description

It was reported that during the procedure after the anchor was implanted, the inserter would not disengage from the anchor.The anchor came out with the handle.The surgeon found that the inner plug of the anchor was broken and could not fix the sutures in the proper position.A backup device was used to complete the surgery.

Manufacturer Narrative

The inner shaft no longer engages with the anchor.The shaft will not advance.This condition can occur when backed off over the recommended amount; causing disengagement.Ifu warning states ¿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.¿ the inner insertion shaft distal tip is also spinning off axis.Per ifu: ¿establish and maintain axial alignment of the suture anchor to the prepared insertion site, and place the tip of the anchor into the prepared hole¿.No root cause related to the manufacturing of this device can be established.No further investigation warranted.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR, 5.5
• 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: 6538695
• MDR Text Key: 74369188
• Report Number: 1219602-2017-00453
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202902
• Device Lot Number: 50614824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Weight: 49