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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 10MMX16CM RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. HFN 10MMX16CM RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71701016R
Device Problems Connection Problem (2900); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Event Description
It was reported that a malfunction occurred during surgery. The hfn nail, out of 5 screws only 3 screws were going through the jig. Remaining 2 screws went out of the nail when surgeon tried this in case. At the same time when surgeon loaded the nail on jig the drill bit went through the holes but not on table when it was used with patient. There was a delay of 1 hour since there was no back up available. Surgeon used the traditional technique she put free hand screws without jig. There was no affectation or injury to patient.
 
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Brand NameHFN 10MMX16CM RIGHT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8101222
MDR Text Key128253730
Report Number1020279-2018-02575
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K043052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71701016R
Device Lot Number17GM10252
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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