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

Model Number 72202682

Device Problem Positioning Failure (1158)

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

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during arthroscopy, while tightening the orange straps on the active heel traction boot the bolt/washer that holds these straps in place snapped and broke away from the boot.It is unknown if there was a delay or how was the procedure completed.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 dhr review could not be performed because the serial number was not provided.A complaint history review found no other related failures.Factors that are known to contribute to the alleged fault/failure may be shipping damage, component failure, or handling.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.Our quality department will continue to monitor for trends.

• 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: 10425776
• MDR Text Key: 203502608
• Report Number: 3003604053-2020-00082
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554024807
• UDI-Public: 00885554024807
• 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
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202682
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1