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

Catalog Number 72202682

Device Problem Mechanics Altered (2984)

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

Event Date 06/03/2015

Event Type  malfunction  

Event Description

Approximately 30 minutes into a hip arthroscopy procedure, it was reported that the middle buckle was opened spontaneously with a slapping sound.The buckle was tightened again, but the patient's foot was slipped from the boot without the strap unbuckling.It was retightened again and the operation was continued.No patient injury was reported.The event caused a 10 minute delay in the procedure.The device was checked by qa team, was found to be intact and will not be returned for evaluation.Additional information received indicated that there was no difficulty snapping the buckle together; it seems completely intact.The patient¿s foot was covered with cotton cloth instead of the foot pad.The user facility has not used the boot with the pad before; they have used cotton cloths instead.This is the first instance of this type of event happening.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation of the ahtb active heel traction boot device was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to this fact, we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4910508
• MDR Text Key: 6026492
• Report Number: 3003604053-2015-00061
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2015
• Date Device Manufactured: 12/05/2014
• 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