MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CARRIAGE RPLT ACTIVE HEEL TRAC BOOT; COMPONENT, TRACTION, NON-INVASIVE

Model Number 72204018

Device Problems Positioning Failure (1158); Unstable (1667)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during an arthroscopic hip surgery, the active heel traction boot was slipping from its positioning because the carriage was coming loose.It looks as if the screw that holds this in place was not as tight or might have rounded off.Surgery was completed with the same reported device.Surgery was not delayed as consequence of the allegation.The patient was not harmed.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.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 review of the manufacturing records could not be performed because the serial number were not provided.A complaint history review found no related failures.Factors that are known to contribute to the alleged fault/failure may include mishandling during shipping, use or reuse of the device, contact with another source, or wear and tear over time.If the product is returned in the future the complaint can be reopened and evaluated.No further investigation is required.

• Brand Name: CARRIAGE RPLT ACTIVE HEEL TRAC BOOT
• Type of Device: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9696407
• MDR Text Key: 187747763
• Report Number: 3003604053-2020-00005
• Device Sequence Number: 1
• Product Code: KQZ
• UDI-Device Identifier: 00885554032215
• UDI-Public: 00885554032215
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204018
• Device Catalogue Number: 72204018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1