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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED
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SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 72202682
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during a hip surgery, the new boot and arm don't slide smoothly together, it is very rigid and hard to get the traction set, doctor said that it is too tight and hard to get distraction.A delay grater that 30 minutes was reported and no back up device was available.No patient injuries were reported.
 
Manufacturer Narrative
H10.H3, h6: visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Correction in g3, user facility should be marked.
 
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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 Key8918569
MDR Text Key156472595
Report Number3003604053-2019-00095
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 company representative,foreig
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
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 Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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