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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 Fracture (1260); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2020
Event Type  malfunction  
Event Description
It was reported that during arthroscopy surgery, whilst distracting the patient's leg the thread on the silver part of the distractor seemed to snap and come off on the other long threaded column. The kit was been properly use and not excessive strain was applied to the product. There was a delay of greater than 30 min and the procedure was completed using a s+n backup device. No patient injury or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10372411
MDR Text Key201855636
Report Number3003604053-2020-00073
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
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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