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

Model Number 72202902

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during cuff surgery, when feeling the finishing tension of the sutures in the inserted footprint anchor, the sutures came up of the anchor.The anchor was left in the patient.The procedure was completed without significate delay using a back-up device in an unplanned additional bone hole.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: do not attempt to implant this device within cartilage epiphyseal growth plates or non-osseous tissue.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.Do not remove the retention suture from the inserter before the anchor is properly secured in the insertion site.The retention suture can be used to retrieve the anchor should it disengage prior to being inserted into the bone.Do not use sharp instruments to manage or control the suture.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10796130
• MDR Text Key: 214993534
• Report Number: 1219602-2020-01775
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650535
• UDI-Public: 03596010650535
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202902
• Device Catalogue Number: 72202902
• Device Lot Number: 2055704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention