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

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

Patient Problems Ossification (1428); Pain (1994); Hip Fracture (2349); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Kumar, g; et al (2015) treatment of unstable intertrochanteric fractures with proximal femoral fail anti-rotation ii: our experience in indian patients.Open ortho journal, 6: 456-459.This report is for an unknown pfna ii system (unknown quantity/unknown lot).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.For nail protrusion, persistent distraction at the fracture site, mismatched nail between proximal end of nail, secondary varus, and limp.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after subsequent review of the following literature article: kumar, g; et al (2015) treatment of unstable intertrochanteric fractures with proximal femoral fail anti-rotation ii: our experience in indian patients.Open ortho journal, 6: 456-459.The purpose of this retrospective study was to evaluate the functional and radiological outcome of proximal femoral nail anti-rotation ii in the treatment of unstable intertrochanteric fractures in indian patients.From january 2011 to march 2013, 45 unstable intertrochanteric fractures treated with the pfna ii (synthes, solothurn, switzerland), were followed retrospectively.Three patients died within 6 months of follow up.There were 26 men and 16 women with mean age of 61 years (range, 35 - 90).All surgeries were carried out at our tertiary care level 1 trauma centre within a mean of six days (range 2-12 days) from date of injury.The proximal end of nail was protruded from the tip of greater trochanter in 3 patients who experience anterior thigh pain.Intra operative fracture of greater trochanter was noted in 6 patients.Two patients had persistent distraction at the fracture site while passing the nail intra-operatively.Four patients with mismatched nail between proximal end of nail and greater trochanter noted even after placing blade in the inferior position.Two cases of fascia lata pain were noted due to laterally protruding helical blades.Implant removal was done in two patients due to persistent anterior thigh pain.Secondary varus was detected in two patients on final follow up radiographs.Six patients had persistent limp.A (b)(6) year old male patient, shows fracture union with nail tip impinging on anterior femoral cortex causing persistent thigh pain.Two patients who were not ambulatory, one had severe parkinson¿s disease and the other had heterotopic ossification.A copy of the literature article will be attached to the medwatch.This report is 1 of 2 for (b)(4).This report is for an unknown pfna ii system and refers to the serious injury of 3 unknown patients who experienced end of nail was protruded from the tip of greater trochanter and anterior thigh pain, 6 patients had intra-operative greater trochanter fracture, 2 patients had persistent distraction at the fracture site while passing the nail intra-operatively; 4 patients with mismatched nail between proximal end of nail, 2 patients had fascia lata pain, 2 patients had implant removal, 2 patients had secondary varus, 6 patients had persistent limp and 1 patient had heterotopic ossification.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6281978
• MDR Text Key: 65897280
• Report Number: 2520274-2017-10295
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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?: No
• Date Manufacturer Received: 01/16/2017
• 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