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

Model Number	72202682
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the active heel traction boot was not holding tight.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual assessment was performed and showed the two o-ring that hold the heal pad were missing.This damage is caused by wear from use.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no other related failures.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.

• 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: 10452346
• Report Number: 3003604053-2020-00092
• Device Sequence Number: 3557806
• Product Code: HST
• UDI-Device Identifier: 00885554024807
• UDI-Public: 00885554024807
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/31/2020

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: No Information
• Device Model Number: 72202682
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1