• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number 04.038.400S
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 05/17/2019
Event Type  malfunction  
Event Description
The patient underwent an open reduction and internal fixation (orif) of the left hip for a left hip fracture due to a fall at home. Notes from the operative report: "the guidewire for the synthes tfn nail was inserted into the proximal femur. After this was completed, the proximal femur was reamed. Next, the fracture reduction tool was used to achieve reduction of the fracture and get past the fracture fragment. The ball-tipped guidewire was then passed into the diaphysis of the femur down to the distal femur. Nail length of 420 mm was chosen. Next, sequential reaming was completed up to a 13. 5 mm reamer with plans for a 12 mm diameter nail. The 12x420 nail was assembled on the back table and then inserted into the femur. Fine tuning adjustments were made and the guidewire for the cephalomedullary device was placed. This was measured for a 100 mm helical blade. The femoral neck and head was drilled and the helical blade was impacted into position. The nail was locked for rotation. After this was completed, 2 distal interlocking screws were placed. Final fluoroscopic imaging was obtained. Thorough irrigation was completed at surgical wounds. The wounds were closed in standard fashion and standard surgical dressings were placed. The patient was awakened from anesthesia and taken to recovery room in satisfactory condition. " the patient was discharged to in-patient rehab facility. The patient had progressive pain and decreased movement of the left leg. There was no history of any subsequent fall or trauma to left hip while in the rehab facility. Two weeks later: left hip xray: impression: status post orif left femoral fracture. There is improved anatomic alignment but continued irregularity and deformity in the region of the left lesser trochanter. Hardware is intact. Ct left lower extremity: findings: there is a dynamic hip screw and intramedullary rod in the left femur. There is a comminuted intratrochanteric fracture that has been reduced with the hardware. The fracture involves both the greater and lesser trochanters. The bone fragments are in anatomic or near anatomic alignment. There is a small volume of fluid around the fracture site. There is no acetabular or pubic rami fracture. The consulting orthopedist noted: impression: left hip pain s/p orif with displacement of fracture fragments and loss of fixation, appears to have a large spike of bone in vastus lateralis with pain. Two days later: the patient underwent left femur hardware removal and left intertrochanteric and subtrochanteric femur revision open reduction and internal fixation. Notes from operative report "using the patient's previous surgical incisions the synthes titanium trochanteric femoral nail was removed, placed on the back table for inspection. There appeared to be rotational instability proximally with a large cavernous proximal femur and as such intertan was selected for greater proximal control and purchase in osteoporotic bone. A guidewire was then placed on the intramedullary canal. The femur was subsequently reduced with clamp open accessory incision. A 2-0 stainless steel wire was then tensioned and crimped to maintain reduction. The proximal femur was then sequentially reamed up to a size femoral shaft was reamed to a 14. 5, was sufficient chatter at 14 noted. A 13cm nail was then paced down the intramedullary canal. Two proximal screws were placed achieving rotational control proximally and 2 distal interlocking screws were placed achieving purchase and fixation. Final fluoroscopic images were taken and saved and showed an anatomically reduced proximal femur construct that was rotationally stable. ".
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
35 airport rd.
horseheads NY 14845
MDR Report Key8657883
MDR Text Key146636902
Report Number8657883
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/20/2019,05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.400S
Device Catalogue Number04.038.400S
Device Lot NumberH771531
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/20/2019
Event Location Hospital
Date Report to Manufacturer05/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage