MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

Catalog Number UNK - ELASTIC NAILS: TITANIUM

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 review of the following journal: mendoza-balta rj, bello-gonzalez a, rosas-cadena jl (2009), titanium elastic nailing of diaphyseal fractures in children, acta ortopédica mexicana.Volume 23, page 286-291, (mexico).The purpose of this study is to report our experience and benefits in the management of diaphyseal fractures in children using titanium elastic nails (tens).From july 1, 2006 to july 1, 2007, 27 children with a diagnosis of diaphyseal fractures of the femur, tibia, humerus, or forearm, with closed or open grades i and ii, occurring within the last 8 hours that are unilateral or bilateral and were treated with tens were included in the study.There were 22 males and 5 females with a mean age of (b)(6) years.All patients were implanted with an unknown synthes titanium elastic nail.Complications were reported as follows: a total of 19 patients had postoperative residual angulation.2 patients with humerus fractures had valgus angulation of 7 degrees.1 patient with humerus fracture had varus angulation of 10 degrees.4 patients with forearm fractures had valgus angulation between 2 degrees and 6 degrees.3 patients with forearm fractures had varus angulation between 2 degrees and 20 degrees.1 patient with forearm fractures had antecurvatum with 3 degrees angulations.2 patients with forearm fractures had recurvatum with 3 degrees angulations.1 patient with tibia fracture had valgus angulation between 3 degrees and 5 degrees.1 patient with tibia fracture had antecurvatum between 3 degrees and 5 degrees angulation.1 patient with femur fracture had varus angulation of 18 degrees.1 patient with femur fracture had varus angulation of 10 degrees.1 patient with femur fracture had recurvatum of 10 degrees angulation.1 patient with femur fracture had antecurvatum of 26 degrees angulation.7 patients had lengthening.2 patient had 2 mm shortening.A (b)(6) year-old male patient had recurvatum with 3 degrees angulation.This report is for the unknown synthes titianium elastic nail.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11777455
• MDR Text Key: 263539783
• Report Number: 8030965-2021-03582
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - ELASTIC NAILS: TITANIUM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/05/2021
• 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