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

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

Patient Problems Skin Irritation (2076); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown elastic nail/ unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Implant date is between january 2012 and december 2017.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.(b)(4).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: langenhan r., bushuven s., reimers n., probst a., (2020) s-shaped titanium endomedullary nail reduces telescoping of comminuted midshaft clavicular fractures,european journal of orthopaedic surgery & traumatology xxxxx, pages 1-8, (germany).This study aims to compare fracture telescoping after imn in comminuted, severely shortened clavicular fractures (ao/ota type 15.2c) with the fracture telescoping of two and three part fractures (ao/ ota type 15.2a/15.2b) that stops until the lateral main fragment gets into contact with the medial main fragment.Between january 2012 and december 2017, a total of 128 patients with displaced midshaft clavicular fractures (dmcf) met the inclusion criteria and classified according to the ao/ota classification system.Group i had 68 patients (11 females, 57 males) with mean age of 34.77 years (sd 15.099) (with 15.2a and 15.2b fractures), while group ii had 60 patients (6 females, 54 males) with mean age of 43.2 years (sd 15.041) (with 15.2c fractures).Stabilization was done using a 2- to 3-mm titanium endomedullary nail (ten, synthes, umkirch, germany).The ten was removed in 125 patients after an average of 17.4 weeks (sd 10.303) when fracture union was confirmed clinically and radiographically.The following complications were reported as follows: 1 patient died after 6 months because of cancer.(excluded patient).One day after surgery the fractured clavicles were slightly longer in both groups in comparison to the unfractured clavicles (pld group i: 1.2%, pld group ii: 0.9%).This could be an intraoperative overcorrection of the clavicular lengths in both groups.During fracture healing, we observed telescoping of the fractured clavicles in both groups.Nonunion: 1 in group i and 2 in group ii.Skin irritation: 2 in group i and 4 in group ii but no skin penetration, over the sternal end of the clavicle.One patient underwent minor operative revision under local anaesthesia with a normal course of fracture healing.Preterm ten removal (after week 5 and 6) was necessary in the other five patients.After ten removal, no dislocation of the fracture fragments occurred.In five of six patients with skin irritation, the fractures healed, while one patient showed a symptomatic delayed union after three months.Two other patients developed symptomatic nonunion without preterm ten removal.This report is for an unknown synthes titanium endomedullary nail (ten).This report is for one (1) unknown elastic nails.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10773701
• MDR Text Key: 216885508
• Report Number: 8030965-2020-08497
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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
• Date Manufacturer Received: 10/07/2020
• 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