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

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

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Pain (1994)

Event Date 10/31/2014

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for proximal femoral nails, unknown quantity, unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or pert number was 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 literature article, zehir s., et al.(2015).Proximal femoral nail antirotation against dynamic hip screw for unstable trochanteric fractures; a prospective randomized comparison.Eur j trauma emerg surg, 41:393-400.This study sought to determine whether intramedullary fixation with proximal femoral nail antirotation produces comparable outcomes to dynamic hip screw in the treatment of unstable trochanteric fractures.Patients were randomly allocated to receive proximal femoral nail antirotation (group 1) or dynamic hip screw (group 2).Patients were randomly allocated to receive pfna (synthes-(b)(4)) (group 1, n = 96, mean age; 77.22 +/- 6.82 years, male:female ratio 0.62) or dhs (synthes-(b)(4)) (group 2, n = 102, mean age; 76.86 +/- 6.74, male:female ratio 0.62) for operative treatment of the fracture.The study was conducted in a (b)(6) hospital and the study group comprised patients who were operated on for unstable trochanteric fractures between january 2010 and march 2013.In-hospital mortality occurred in eight patients who were aged between 72 and 91 years.Six of these deaths were due to cardiac failure and two due to sepsis and multiorgan failure.The following complications were noted in dhs group: deep wound infection(4), hematoma(4), cutout(8), pain at hip(3), pain at thigh(2), reoperation(3).Three patients in the dhs group underwent hip arthroplasty for severe cutout and loss of reduction.The following complications were noted in pfna group: hematoma(2), cutout(7), screw migration(5), pain at hip(3), pain at thigh(7).Six patients (three in the pfna group and three in the dhs group, p = 0.94) had new trochanteric fractures and two (one in the pfna group and one in the dhs group) had new femoral shaft fractures until the 6-month follow-up.This is report 3 of 5 for (b)(4).This report is for proximal femoral nails and refers to the serious injuries of hematoma, pain at hip, pain at thigh, new trochanteric fractures, and a new femoral shaft fracture.

• 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: 5094682
• MDR Text Key: 26468357
• Report Number: 2520274-2015-16033
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• 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
• Date Manufacturer Received: 09/04/2015
• 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