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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 Unstable (1667); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, the handle of the "ahtb universal hip distractor" was bent, so it did not stay in one position. No case reported; therefore, there was no patient involvement. 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
MDR Report Key11333776
MDR Text Key232039020
Report Number3003604053-2021-00045
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
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 Manufacturer08/11/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
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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