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

Model Number 72201725

Device Problems Positioning Failure (1158); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

Manufacturer Narrative

H11.Correction in d1, d2 and d4.

Manufacturer Narrative

H10: 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.

• 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
• MDR Report Key: 9814132
• MDR Text Key: 183482849
• Report Number: 3003604053-2020-00013
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 03596010612816
• UDI-Public: 03596010612816
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201725
• Device Catalogue Number: 72202682
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1