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

Model Number	72203275
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that active heel traction boot replacement kit was loosening and it was not maintaining tension on the boot causing the patient´s foot to slide, ultimately impacting distraction.This was noticed before the procedure; therefore, no patient was involved.A backup device was available and no delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: STRAP RPLT 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: 11273820
• Report Number: 3003604053-2021-00026
• Device Sequence Number: 4607308
• Product Code: HST
• UDI-Device Identifier: 03596010656377
• UDI-Public: 03596010656377
• 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
• Report Date (Section B): 03/16/2021

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: 72203275
• Device Catalogue Number: 72203275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1