Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 72202682
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2019
Event Type  malfunction  
Event Description
It was reported that during a hip arthroscopy, the ball and socket were moving.The procedure was completed with a backup device with no delay or patient injury reported.
 
Event Description
It was reported that during a hip arthroscopy, the ball and socket were moving.The procedure was completed with a backup device with no delay or patient injury reported.No loss of traction was caused due to the device malfunction.
 
Manufacturer Narrative
Additional information was received from reporter stating that there was no loss of traction during the surgical procedure.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8936651
MDR Text Key156472928
Report Number3003604053-2019-00102
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72202682
Was Device Available for Evaluation? No
Date Manufacturer Received08/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-