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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR APPARATUS, TRACTION, NON-POWERED

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SMITH & NEPHEW, INC. KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 72203272
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Patient Involvement (2645)
Event Date 10/14/2020
Event Type  malfunction  
Event Description
It was reported that the ball joint of the kit ahtb retrfit hardware is getting stuck. No case was involved. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameKIT AHTB RETRFIT HARDWARE UNIV HIP DISTR
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 Key10804983
MDR Text Key215287382
Report Number3003604053-2020-00143
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72203272
Device Catalogue Number72203272
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2021
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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