MAUDE Adverse Event Report: SYNTHES USA; PIN, FIXATION, SMOOTH

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Date of event: chaudhary, d (2012).The proximal femoral nail ¿ a minimal invasive treatment for the stabilization of pertrochanteric and subtrochanteric femoral fractures.Jk science, vol.14, no.3, pp.120-124.India.This report is for unknown pin/unknown quantity/unknown lot.Unknown part number, udi unavailable.(b)(4): for secondary varus.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.

Event Description

This report is being filed after the subsequent review of the following literature article: chaudhary, d (2012).The proximal femoral nail ¿ a minimal invasive treatment for the stabilization of pertrochanteric and subtrochanteric femoral fractures.Jk science, vol.14, no.3, pp.120-124.India.This randomized prospective study was conducted to determine the suitability of proximal femoral nail (pfn) as an appropriate method for minimal invasive treatment of pertrochanteric & subtrochanteric femoral fractures.Participants included 17 males and 8 females, with a mean age of 56.3 years.Post-surgery follow ups were at 2 weeks interval for the first 3 months, and then 4 weeks interval til the fracture union or fixation failure.The salvati and wilson hip scoring system, kyles criteria, and radiographic analysis were used at follow up assessment.At 6 months follow up, the ambulatory status was assessed to include the need for assistance devices and pain felt on weight bearing.The following complications were reported: secondary varus was noticed in 3 cases.This was due to external migration of the femoral neck screw and antirotation hip pin with collapse of the fracture site.This is report 4 of 4 for (b)(4).This report is for an unknown pins.

• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5803777
• MDR Text Key: 49857129
• Report Number: 2520274-2016-13519
• Device Sequence Number: 1
• Product Code: HTY
• 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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/19/2016
• 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