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
H10: h2, h3, h6: the device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.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 other related failures.Factors that are known to contribute to the alleged fault/failure may be shipping damage, a component failure, or wear from use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.

• 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: 10451663
• Report Number: 3003604053-2020-00088
• Device Sequence Number: 16973323
• 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): 09/30/2020

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: Health Professional
• Device Model Number: 72202682
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1