MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED

Catalog Number 72202682

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/18/2017

Event Type  malfunction  

Event Description

It was reported that the heel pad has detached from the boot.The glue has failed.The doctor asked for more traction and wasn¿t able to apply it because of excessive heel lift-off.The procedure was completed with the same device.No patient injuries were reported.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.

• Brand Name: AHTB ACTIVE HEEL TRACTION BOOT
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 w william cannon drive; austin, TX 78735
• MDR Report Key: 7167243
• MDR Text Key: 96709601
• Report Number: 3003604053-2018-00005
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554029673
• UDI-Public: (01)00885554029673
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1