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

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

Patient Problems Rupture (2208); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Lee, a.K.Et al (2016) incidence and risk factors for extensor pollicis longus rupture in elastic stable intramedullary nailing of pediatric forearm shaft fractures.J pediatr orthop 36(8):810-815.This report is for unknown titanium elastic nail system, unknown quantity, unknown lot.(b)(4).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.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article: lee, a.K.Et al (2016) incidence and risk factors for extensor pollicis longus rupture in elastic stable intramedullary nailing of pediatric forearm shaft fractures.J pediatr orthop 36(8):810-815.A retrospective review of all patients younger than 19 years who had a repair of a forearm fracture with flexible intramedullary nailing between 2006 and 2011 was performed.Nineteen consecutive patients were identified from the electronic medical record.All patients were treated with synthes ((b)(4)) titanium elastic nail system using a percutaneous, dorsal approach to the radius as described by walz with retrograde implantation of the flexible nail.The patients were followed postoperatively for at least 2 years, and all fractures healed.Seventeen records were available for review.Fourteen (82%) were male, and the mean age at time of fracture was 10 years old (range, 5 to 14 y).Follow-up averaged 5.5 years (range, 2.9 to 7.8 y).The mean weight was 32.7 kg for males and 50.6 kg for females corresponding to the 61st and 60th percentile respectively of weight-for-age (range, 8th to 99.9th percentile).Three of the 17 patients (18%) experienced rupture of the epl.Two were treated with additional surgery following hardware removal, and one was untreated due to patient preference.This is report 1 of 1 for (b)(4).This report is for an unknown titanium elastic nail system.

• 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: 6387782
• MDR Text Key: 69374144
• Report Number: 2520274-2017-10779
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• 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: 02/14/2017
• 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