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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 03/13/2009

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).This report is for an unknown titanium elastic nail / unknown quantity / unknown lot.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.

Event Description

This report is being filed after the subsequent review of the following journal article: garg s.Et al.(2016).Surgical treatment of traumatic pediatric humeral diaphyseal fractures with titanium elastic nails.J child orthop (2009) volume 3: pages121¿127.Usa.This is a retrospective review of all traumatic humeral shaft fractures treated between 1999 and 2006.Thirteen pediatric patients (eight boys, five girls) ranging in age from 4.8 to 16.7 years (mean age 12.0 years) were treated surgically with titanium elastic nails (tens) (synthes,(b)(4)).The patients were followed for a mean of 29 months.One patient (12 years, male) had nail migration distally and required a return trip to the operating room to have his nails trimmed.This is report 1 of 2 for (b)(4).This report is for unknown titanium elastic nail system.

• 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: 5894042
• MDR Text Key: 52673243
• Report Number: 2520274-2016-14274
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• 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: 07/27/2016
• 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: 12 YR