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

Model Number	72202682
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7252900
• Report Number: 3003604053-2018-00023
• Device Sequence Number: 997745
• Product Code: HST
• UDI-Device Identifier: 00885554024807
• UDI-Public: (01)00885554024807
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR