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

Model Number	72201725
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy, the strap which secures the foot into the active heel traction boot broke since it was routinely over tighten.Since there was not any back-up device available, it is unknown how the procedure was completed; nevertheless, the procedure was not delayed and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H11.Correction in d1, d2 and d4.
Additional Manufacturer Narrative
H3,h6: the device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A dhr review was not performed because the serial number was not provided.A complaint history review found other related failures.Factors that are known to contribute to the alleged fault/failure may include worn straps or a defective buckle.If the product is returned in the future the complaint can be reopened and evaluated.This failure mode will be trended to assess for any necessary corrective actions.No further investigation is required.

• 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: 9808750
• Report Number: 3003604053-2020-00012
• Device Sequence Number: 778129
• Product Code: HST
• UDI-Device Identifier: 03596010612816
• UDI-Public: 03596010612816
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2020

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: 72201725
• Device Catalogue Number: 72202682
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 04/03/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/02/2020; 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1