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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. MEDIUM HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631066
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2020
Event Type  malfunction  
Event Description
It was reported that during the procedure the gold screw was tough to thread into the driver (this occurred inside the patient). Also, the threads on the driver were worn. The procedure was completed without delay and with the same device. Patient injuries were not 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 NameMEDIUM HEXDRIVER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks rd.
memphis, TN 38116
0447940038
MDR Report Key10446380
MDR Text Key204160410
Report Number1020279-2020-04170
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
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
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631066
Device Catalogue Number71631066
Device Lot Number17DM03278
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 Received04/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/05/2017
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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