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

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Infiltration into Tissue (1931); No Code Available (3191)

Event Date 04/15/2014

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: lu, c.-c.Et al (2014) complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 37(4), e377-e383.From january 2007 to april 2008, 27 patients (17 men, 10 women; mean age 45.8 years; range 16.5-66.9 years) with marked displaced midclavicular fractures underwent fixation with titanium elastic nails (synthes, (b)(4)).No infection, nonunion, nail dislocation, or implant breakage occurred and all procedures healed without secondary procedures.A (b)(6) male experienced severe tip prominence/protrusion and bone shortening that required implant removal.This is report 2 of 4 for (b)(4).This complaint is for an unknown titanium elastic nail.This report is for 1 devices.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Lu, c.-c.Et al (2014) complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 37(4), e377-e383.This report is for an unknown titanium elastic nail.(b)(4).Bone shortening.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: NAIL, FIXATION, BONE
• 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: 4108840
• MDR Text Key: 21448524
• Report Number: 2520274-2014-13708
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• 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?: Yes
• Date Manufacturer Received: 09/03/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR