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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SYNTHES TROCHANTERIC FIXATION NAIL (TFN)

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SYNTHES SYNTHES TROCHANTERIC FIXATION NAIL (TFN) Back to Search Results
Lot Number H737070
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Perforation (2001)
Event Date 01/22/2019
Event Type  Injury  
Event Description
Pt s/p fall w / left hip fracture and repair w/ long tfn (trochanteric fixation nail). F/u one month later; denied falls or trauma, x-rays showed the screw had "protruded through into the bladder area and extruded medially. Pt returned to surgery.
 
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Brand NameSYNTHES
Type of DeviceTROCHANTERIC FIXATION NAIL (TFN)
Manufacturer (Section D)
SYNTHES
MDR Report Key8514811
MDR Text Key142027081
Report Number8514811
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberH737070
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2019
Distributor Facility Aware Date03/06/2019
Device Age6 WK
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/02/2019 Patient Sequence Number: 1
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