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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 Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2018
Event Type  malfunction  
Event Description
It was reported that the strap/buckle which goes around the ankle (ankle distractor boot for hip arthroscopy) pops out. No back-up device was available. No patient injury reported.
 
Manufacturer Narrative
An evaluation was performed by smith & nephew and could not confirm the customer complaint for the strap/buckle which goes around the ankle pops out. A visual inspection was performed and showed the o-rings are snapped off not holding the ankle pad in place and the orange straps are worn. This damage is caused by normal wear. There is no damage to the buckle. It connects properly without disconnecting.
 
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Brand NameAHTB ACTIVE HEEL TRACTION BOOT
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7362912
MDR Text Key103321210
Report Number3003604053-2018-00048
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 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

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