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

Catalog Number 72202682F

Device Problem Device Slipped (1584)

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

Event Date 09/20/2018

Event Type  malfunction  

Event Description

It was reported that the boot straps kept slipping.There was a surgical delay greater than 30 minutes.

Manufacturer Narrative

An evaluation was performed and could not confirm the customer complaint for the boot straps kept slipping.A visual inspection was performed and showed the back pad was not returned with the boot for evaluation.One of the o ring that holds the ankle pad is snapped off.The orange straps appear to be in good condition.There is no damage to the buckles.Due to the pad not being returned and the o ring being snapped off a full evaluation could not be completed.Smith and 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 78735 ; 5123585706
• MDR Report Key: 7945331
• MDR Text Key: 123204664
• Report Number: 3003604053-2018-00159
• Device Sequence Number: 1
• Product Code: HST
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202682F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• 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: Unknown
• Patient Sequence Number: 1