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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
Catalog Number 72203272
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2019
Event Type  malfunction  
Manufacturer Narrative
As per reported the patient is a male, he is at early 20s.
 
Event Description
It was reported that the boot snapped off the holder during a hip arthroscopy while the patient was on traction. No patient injuries were reported. Back-up device was available to complete the surgery. Delay greater than 30 minutes was reported.
 
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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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8497620
MDR Text Key141459967
Report Number3003604053-2019-00044
Device Sequence Number1
Product Code HST
UDI-Device Identifier03596010656346
UDI-Public03596010656346
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
Type of Report Initial,Followup,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72203272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
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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