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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB UNIVERSAL HIP DISTRACTOR; APPARATUS, TRACTION, NON-POWERED
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SMITH & NEPHEW, INC. AHTB UNIVERSAL HIP DISTRACTOR; APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 72203270
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during the surgery the ball joint on ahtb attachment would not lick in place adequately when the patients leg was in the boot.The surgical assistant had to hold the leg in the required position for the surgeon.No back up device was available.No patient injury or other complications were reported.
 
Manufacturer Narrative
An evaluation was performed by smith and nephew and could not confirm the customer complaint for the ball joint on ahtb attachment would not click in place adequately.This device was manufactured in 2013.A visual inspection was performed and showed cosmetic damage only.Functional inspection was performed and showed when the hip distractor was attached to the table attachment the device connected properly.No manufacturing related defects were observed.
 
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Brand Name
AHTB UNIVERSAL HIP DISTRACTOR
Type of Device
APPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8275893
MDR Text Key134091358
Report Number3003604053-2019-00007
Device Sequence Number1
Product Code HST
UDI-Device Identifier00885554024821
UDI-Public00885554024821
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 03/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72203270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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