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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 Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 10/13/2017
Event Type  malfunction  
Event Description
It was reported by customer that device presented traction issues.
 
Manufacturer Narrative
An evaluation was performed by smith & nephew and could confirm the customer complaint for the device presented traction issues.A visual inspection was performed and showed the traction handle is missing and was not returned and the orange tightening knob on the carriage is damaged causing the knob to be jammed.Smith & nephew is unable to determine what caused this damage.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
james gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6989565
MDR Text Key91252525
Report Number3003604053-2017-00317
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,consum
Type of Report Initial,Followup
Report Date 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
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 Manufacturer10/20/2017
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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