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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.
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Manufacturer (Section D)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
MDR Report Key6387782
MDR Text Key69374144
Report Number2520274-2017-10779
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
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 Received03/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/08/2017 Patient Sequence Number: 1