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

Device Problems Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)

Patient Problem Impaired Healing (2378)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: chun, y., oh, h., cho, y.And rhyu, k.(2011), technique and early results of percutaneous reduction of sagittally unstable intertrochanteric fractures.Clinics in orthopedic surgery, 3, 217-224.The authors conducted a study to compare a percutaneous reduction technique using one or two steinman pins to reduce sagittally unstable intertrochanteric fractures versus a control group.Sagittal displacement was stabilized with synthes device, proximal femoral nail antirotation (pfna).One hundred nineteen intertrochanteric fractures in 115 patients aged 65 years or older were treated from june 2007 to december 2008.Of them, 21 hips in 20 patients showed sagittal instability (study group); nineteen hips were followed up for more than one year.Clinical and radiological results of the study group were reviewed and compared with those of the remaining cases who did not show sagittal instability (control group).Results included two hips with cutout in the control group; these two did not achieve union.This is report 2 of 2 for (b)(4).This report is for an unknown pfna.

Manufacturer Narrative

This device was used for treatment, not diagnosis.Chun, y., oh, h., cho, y.And rhyu, k.(2011), technique and early results of percutaneous reduction of sagittally unstable intertrochanteric fractures.Clinics in orthopedic surgery, 3, 217-224.This report is for an unknown pfna/unknown quantity/unknown lot.Hwc, screw, fixation, bone.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: ROD, FIXATION, INTRAMEDULLARY
• 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: 4229861
• MDR Text Key: 4975855
• Report Number: 2520274-2014-14549
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/06/2014
• 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