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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
Model Number 72203270
Device Problems Mechanical Problem (1384); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
An evaluation was performed by smith & nephew and could not confirm the customer complaint for an issue with the ball joint socket. A visual inspection showed the carriage assembly is broken. The assembly is snapped at the base and the traction post is severely bent and detached causing it not to rotate and the bellow (protective cover) is torn from the ball joint causing the ball joint to be exposed. 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.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the ball/socket joint at the table attachments end cannot hold the leg in place. No patient injury reported.
 
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Brand NameAHTB UNIVERSAL HIP DISTRACTOR
Type of DeviceAPPARATUS, 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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7117468
MDR Text Key195008201
Report Number3003604053-2017-00335
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72203270
Device Catalogue Number72203270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2018
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 Unkown

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