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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 Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the device seems very tight and difficult to move. No patient injury was reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device seems very tight and difficult to move. A visual inspection was performed and showed the t-handle inner rod is bent. This damage is consistent with being dropped or banged. No manufacturing related defects were observed.
 
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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
5123585706
MDR Report Key7828966
MDR Text Key118746457
Report Number3003604053-2018-00133
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72203270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
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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