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

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Wysocki, robert w.Et al.(2009) intramedullary nailing of proximal and distal one-third tibial shaft fractures with intraoperative two-pin external fixation.J trauma 66:1135-1139.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.(b)(4): tibia collapse into valgus.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: wysocki, robert w.Et al.(2009) intramedullary nailing of proximal and distal one-third tibial shaft fractures with intraoperative two-pin external fixation.J trauma 66:1135-1139.Between 2000 and 2005, 15 consecutive patients with proximal third and 27 consecutive patients with distal third displaced extraarticular fractures of the tibia were treated with statically locked intramedullary nailing and supplementary intraoperative two-pin rectangular frame external fixation.Postoperatively, 14 of 15 patients with proximal fractures and 25 of 27 patients with distal fractures had less than 5 degrees of angular deformity in both the coronal and sagittal planes and less than 1cm shortening.All patients were treated with either the hoffman ii external fixation system ((b)(4)) or the large external fixator set ((b)(4)).Thirteen patients were treated with the trigen knee nail ((b)(4)), and the remaining 29 patients were treated with the t2 standard tibial nail ((b)(4)).Postoperative radiographs in the proximal fracture group revealed 14 of the 15 patients to have acceptable alignment with 5 degrees or less angulation in all planes and less than 1cm shortening.Postoperative radiographs in the distal fracture group revealed 25 of the 27 patients to have acceptable alignment with 5 degrees or less angulation in all planes and less than 1 cm shortening.Complications: the patient with 6 degrees of valgus had the external fixator loosened before distal locking because the fixator clamps were blocking insertion of the locking screws, which allowed the tibia to collapse into valgus.This is report 2 of 2 for (b)(4).This report is for an unknown synthes external fixator.

• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 6506523
• MDR Text Key: 73216148
• Report Number: 2520274-2017-11401
• Device Sequence Number: 1
• Product Code: KTT
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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
• Date Manufacturer Received: 03/31/2017
• 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