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

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.

• Brand Name: TROCHANTERIC FIXATION NAIL (TFN)
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES (USA) PRODUCTS LLC
• MDR Report Key: 8403374
• MDR Text Key: 138359013
• Report Number: MW5084736
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: H737070
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 83 YR