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

Model Number	72204018
Medical Device Problem Codes	Positioning Failure (1158); Unstable (1667)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003604053-2020-00005
• Device Sequence Number: 19027086
• Product Code: KQZ
• UDI-Device Identifier: 00885554032215
• UDI-Public: 00885554032215
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

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: 72204018
• Device Catalogue Number: 72204018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 04/11/2024
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/19/2020; 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown