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

Model Number 72202682

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 08/10/2020

Event Type  Injury  

Event Description

It was reported that, after finishing a hip arthroscopy, when the doctor untied the patient from the "traction table boot", a mild abrasion was found on the skin of the patient's left foot; specifically in the haglund deformity in the dorsal ankle area due to her callus/bony deformity.The area was cleaned thoroughly and sterile petroleum jelly gauzes were placed for protection/treatment of skin lesion.It is unknown if there was a delay in the surgical procedure and no further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided images show the active heel traction boot serial number as (b)(6) and two boots attached to the hip distractors.The surgical findings reported the mild abrasion found on the skin of the patient's left foot; specifically in the haglund deformity in the dorsal ankle area due to her callus/bony deformity.However, the root cause of the abrasion cannot be determined.The impact to the patient and the mild abrasion to her left foot.Per report, the surgeon thoroughly cleansed the area and sterile petroleum gauge was placed for protection/treatment of the skin lesion.No further complications were reported, however, it is unknown if there was a delay in the surgical procedure.No further medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include creased pads of the device or failure to eliminate pressure points.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 investigation will be reopened for evaluation.

• 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: holly topping ; w. william cannon drive 7000; austin, TX 78735 ; 5123913906
• MDR Report Key: 10477628
• MDR Text Key: 205135542
• Report Number: 3003604053-2020-00094
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554024807
• UDI-Public: 00885554024807
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202682
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female