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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) PRODUCTS LLC TROCHANTERIC FIXATION NAIL (TFN) ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES (USA) PRODUCTS LLC TROCHANTERIC FIXATION NAIL (TFN) ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Lot Number H737070
Device Problems Collapse (1099); Material Protrusion/Extrusion (2979); Positioning Problem (3009)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 01/22/2019
Event Type  Injury  
Event Description
Patient s/p fall w/left hip fracture and repair w/long tfn (trochanteric fixation nail with a 400 length 100 spiral blade proximally and a 38 distal screw), findings included a significant osteoporotic fx, intertrochanteric, subtrochanteric, w/significant comminution. Pod1: x-rays showed positioning concern with the amount of comminution on the medial side trochanteric area, but good stabilization, no pain on range of motion. Patient ambulatory, full weight-bearing (as tolerated) w/no neurovascular compromise. Patient had ptx postop, d/c pod4. Follow up office visit two weeks later: x-rays ¿looked good, it collapsed a little bit. ¿ patient fully ambulatory, return to office one month. Follow up one month later; denied falls or trauma, x-rays showed the screw had ¿protruded through into the bladder area and extruded medially, not laterally, and did not collapse. The fracture looks in good positioning. ¿ patient ambulatory, denied pain, or hematuria. Provider disclosed to patient and son need for surgery to exchange the rod and replace the screw. Patient returned to surgery for same.
 
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Brand NameTROCHANTERIC FIXATION NAIL (TFN)
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES (USA) PRODUCTS LLC
MDR Report Key8403374
MDR Text Key138359013
Report NumberMW5084736
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
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? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
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: 03/07/2019 Patient Sequence Number: 1
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