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

Model Number 72202682

Device Problem Break (1069)

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

Event Date 01/30/2018

Event Type  malfunction  

Event Description

It was reported that while the patient was under traction and the doctor was operating the center strap of the active heel traction boot busted and the clasp broke.The doctor lost immediate traction.There were no instruments in the joint at the time.Procedure was delayed for more than two hours while getting a backup device to complete the procedure.No patient injury reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the velcro came off and the o-rings snapped around the ankle pad.A visual inspection was performed and showed the velcro was not returned.There is loctite present on the boot and applied within specification however without the velcro pad a complete evaluation can¿t be performed.The o-rings are there to help keep the pad in place while positioning the heel, but once the foot is in and secure they serve no function.The o-rings can break if pulled too hard.Smith & nephew will continue to monitor for trends.

• 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 west william cannon drive; austin, TX
• MDR Report Key: 7252900
• MDR Text Key: 99607149
• Report Number: 3003604053-2018-00023
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554024807
• UDI-Public: (01)00885554024807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202682
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• 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
• Patient Age: 20 YR