MAUDE Adverse Event Report: SYNTHES USA

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Journal article received: femoral neck fracture following intramedullary nailing with misplacement of an end cup: report of two cases; pawe grala, bartosz mankowski and grzegorz kierzynka; journal of orthopedic traumatology (2009) 10:35¿38; reported: two case studies with unusual complications, one of which involved a (b)(6) obese (body (b)(6)) woman with a history of recent implant removal of the left femoral shaft.The patient was implanted with synthes device, universal femoral nail.It was reported that the end cup was misplaced behind the femoral neck.Multiple efforts to remove it using a finger and vascular clamps failed.Subsequently, the patient developed nonunion of both the neck and diaphysis as shown via x-ray.During a subsequent operative intervention, the end cup was replaced and fixation of the femoral neck was attempted with two screws.The screws redisplaced and were removed.The authors reported that the patient remains severely disabled.They attribute complications of this case to technical errors that occurred with the end cup placement at the end of the procedure.This report is for an unknown femoral nail.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis.Device is an unknown femoral nail, quantity 1.Cannot be determined without a part number.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3637833
• MDR Text Key: 20637261
• Report Number: 2520274-2014-00694
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/23/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR