MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Irritation (1941); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment not diagnosis.Boldin, c., et al (2003) the proximal femoral nail (pfn) - a minimal invasive treatment of unstable proximal femoral fractures a prospective study of 55 patients with a follow-up of 15 months, acta orthop scand, 74: 53-58.This report is for an unknown trauma (unknown pfn screw) /unknown quantity/unknown lot.(other number) udi unknown part number, udi is unavailable.The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following article: boldin, c., et al (2003) the proximal femoral nail (pfn) - a minimal invasive treatment of unstable proximal femoral fractures a prospective study of 55 patients with a follow-up of 15 months, acta orthop scand, 74: 53-58.Country of article: austria.This was a prospective study of 55 patients with unstable proximal femoral fractures who were treated between 1997 and 2000 with the ao/asif proximal femoral fractures (pfn).The objective of the study was to evaluate whether the pfn is an appropriate method for minimally invasive treatment of proximal femoral fractures.The mean patient age was 73 (18-95) years, and the gender ratio (male/female) was 16:39.All patients were evaluated by regular physical and radiographical examinations.The mean follow-up period was 15 months (7-30).Postoperative anatomical reduction was achieved in 34 out of 55 patients, and immediate full weight bearing was permitted in 49 patients.The fracture healed in all 55 patients.Complications: 1 patient- had partial implant removal (the hip screw and hip pin) because of irritation to the fascia lata.2 patients- had cut-out of implant because the hip screws used were too short.This report is 1 of 3 for (b)(4).This report is for unknown trauma (unknown pfn screw), unknown quantity and unknown lot number.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5836308
• MDR Text Key: 50825715
• Report Number: 2520274-2016-13749
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention