MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Non-union Bone Fracture (2369)

Event Date 12/07/2012

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Intramedullary nails result in more reoperations than sliding hip screws in two-part intertrochanteric fractures; kjell matre md; leif ivar havelin md, phd; jan-erik gjersten md, phd; birgitte espehaug msc, phd; and jonas meling fevang md, phd; clin orthop relat res (2013) 471: 1379-1386.The article is from norway.This article is a comparative review of outcome after treating a fracture with intramedullary nails (imn) and sliding hip screws (shs).The data used was from the norwegian hip fracture register on 7724 operations.Operations performed with other implants (n = 22) and operations for pathologic fractures (n = 59) were excluded leaving 7643 operations for simple two-part intertrochanteric fractures (ao/ota type a1) treated with an shs (n = 6355) or an im nail (n = 1288) between january 1, 2005 and december 31, 2010.Of these 6355 patients implanted with an shs, 1929 patients (30percent) were implanted with synthes basel dynamic hip screw (dynamic hip system) and 492 patients (8percent) were implanted with synthes basel locking compression plate (dynamic hip system).Of these 1288 patients implanted with an im nail, 51 patients (4percent) were implanted with synthes basel proximal femoral nail-antirotation and 11 patients (0.9percent) were implanted with synthes basel proximal femoral nail.The fractures were classified according to the ao/ota classification and also reported the patients¿ baseline characteristics (age, sex, cognitive function, american society of anesthesiologists [asa] classification of morbidities) and details from the primary operations (surgical time, type of anesthesia, antibiotic and thrombotic prophylaxis).Overall, 71 percent of the patients were female, and the mean age for both groups was 82 years.Failure of the fixation, nonunions or malunions, femoral head necroses, local pain from protruding hardware, infections, hematomas, cutouts, periimplant fractures, and other occurrences were the options for reporting causes of reoperation.Removal of the implants, resection arthroplasties, unipolar or bipolar hemiarthroplasties, refixation, debridement for infections, and other occurrences were the options for reporting type of reoperations.More than one cause of reoperation and more than one type of reoperation were recorded for some patients, but no detailed information regarding the causes of reoperations for these patients.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for 60 reports of reoperated hips (unknown intramedullary nail).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3723164
• MDR Text Key: 4310894
• Report Number: 2520274-2014-10574
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• 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