MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CALF STRAP EQUIPMENT RPLT AHTB; APPARATUS, TRACTION, NON-POWERED

Model Number 72204017

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

Manufacturer Narrative

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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Internal complaint reference: (b)(4).

• Brand Name: CALF STRAP EQUIPMENT RPLT AHTB
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11273876
• MDR Text Key: 230108534
• Report Number: 3003604053-2021-00028
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00885554032208
• UDI-Public: 00885554032208
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204017
• Device Catalogue Number: 72204017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1