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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Paralysis (1997); Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.Additional narrative: this report is for a unknown elastic nail.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 rehm.K.Andermahr, j, jubel,a.Intramedullary nailing of midclavicular fractures with an elastic titanium nail operat orthop traumatol 2004;16:365¿79.(b)(6).The objective of this study was the reduction and intramedullary fixation of midclavicular fractures with an elastic titanium nail with the goal to reduce pain and to quickly resume activities of daily living postoperatively.In eight patients a shortening of the nail at the site of insertion became necessary 1¿33 weeks after the index operation on account of local pain and skin irritation.In three patients with a comminuted fracture we observed radiologically a secondary shortening of the clavicle of 1.5 ± 0.5 cm.In five patients a cortical perforation of the lateral fragment occurred.In one of these patients a nail migration into the lateral soft tissue was seen 2 months after surgery necessitating a premature removal of the nail through a lateral incision.A transient paresthesia of the arm and hand was seen in three patients.We observed one nonunion in a polytraumatized patient.This is report 1 of 1 for (b)(4).This report is for a titanium elastic intramedullary nails.

• Type of Device: NAIL, FIXATION, BONE
• 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: 5865199
• MDR Text Key: 51740731
• Report Number: 2520274-2016-14002
• Device Sequence Number: 1
• Product Code: JDS
• 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: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention