MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; NAIL, FIXATION, BONE

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

Patient Problems Discomfort (2330); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown elastic nails: titanium/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 article: ¿ivanovic, d.Et al (2017), congenital posteromedial bowing of the tibia: a single center experience, acta facultatis medicae naissensis, vol.34 (4), pages 293-300 (serbia).The aim of this single center experience retrospective study is to analyze our experience in the treatment of cpmbt.Between january 2000 to june 2016, a total of 6 patients (1 male and 5 female) were included in the study.In two children, limb lengthening with synthes circular titanium frame of ilizarov type was performed.In the first patient (case 2), lengthening was performed over intramedullary titanium elastic nails (ten).In the second patient (case 4), after completion of distraction, a locking compression plate (lcp) was inserted, and frame was dismounted to reduce fixator wearing time.The mean follow-up period was 6.83 years (2-12 years).Patients with lengthening procedures were followed up for five years and a half.The following complications were reported as follows: case 1: a female patient had mild complications in the form of skin irritation and superficial skin infection around the pins during distraction, which was resolved by the administration of oral antibiotics.Transient peroneal neuropraxia was observed in the final stages of distraction.Nevertheless, the signs of neuropraxia completely resolved over time.Case 4: a female patient had mild complications in the form of skin irritation and superficial skin infection around the pins during distraction, which was resolved by the administration of oral antibiotics.This report is for an unknown synthes ex-fix constructs and unknown synthes titanium elastic nails.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11868827
• MDR Text Key: 265577109
• Report Number: 8030965-2021-04161
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/23/2021
• 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