MAUDE Adverse Event Report: SYNTHES (USA); DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 02/27/2014

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿comparison of proximal femoral nail antirotation (pfna) with ao dynamic condylar screws (dcs) for the treatment for unstable peritrochanteric femoral fractures.¿ sahin, e.K., et al (2013, february, 27).European journal of orthopaedic surgery & traumatology.The purpose of this retrospective study was to compare the results of the dcs (dynamic condylar screw) and the pfna (proximal femoral nail antirotation) in the treatment for unstable peritrochanteric fractures in patients older than 60.This observational study enrolled patients who were treated in our hospital with the dcs (dynamic condylar screw) and the pfna (proximal femoral nail antirotation) for peritrochanteric fractures between january 2007 and december 2010.The patients were divided into two groups.Intramedullary fixation with the pfna (proximal femoral nail antirotation) system (synthes (b)(4)) was implemented in group a (n = 42 (17 male/25 female, mean age 77 years).This group was composed of 42 patients with peritrochanteric fractures (ao classification: 31-a2 in 23 and 31-a3 in 19).Group b (n = 37 (18 male/19 female, mean age 72 years) underwent extramedullary fixation with the dcs (dynamic condylar screw) system (synthes (b)(4)).This group consisted of 37 patients with peritrochanteric fractures.The following orthopaedic complications were reported in the pfna (proximal femoral nail antirotation) group: two lateral migrations of blade or screw, two cut-outs, one infection, and two reoperations (reason for reoperation not provided).The following orthopaedic complications were reported in the dcs (dynamic condylar screw) group: one lateral migration of blade or screw, one cut-out, one nonunion, three infections, two implant failures, and four reoperations (reason for reoperation not provided).It was concluded, owing to some advantages, such as minimal exposure, reduced operative blood loss, and the achievement of biological fixation, pfna (proximal femoral nail antirotation) is a better choice for the treatment for unstable peritrochanteric fractures.This report is for an unknown proximal femoral nail antirotation system (which includes nails, helical blades, and screws), and for an unknown dynamic condylar screw system (which includes plates and screws).

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for unknown dynamic condylar screw plates/unknown lot.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: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• 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: 3726015
• MDR Text Key: 15816842
• Report Number: 2520274-2014-10546
• Device Sequence Number: 1
• Product Code: JDO
• 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
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention