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 Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown titanium elastic nail/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 2008 to july 2015.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: bithrey, jw and van der merwe, jf (2017), outcomes of treatment of displaced midshaft clavicle fractures in adolescents using titanium elastic nails, south african orthopaedic journal, vol.16 (3), pages 55-61 (south africa).The aim of this single-institution, retrospective study is to evaluate the clinical outcomes of managing displaced midshaft clavicle fractures in adolescents using titanium elastic nails.Between january 2008 to july 2015, a total of 15 patients (12 male and 3 female) with a mean age of 14.9 years (range 13¿17 years), were treated surgically by open reduction and internal fixation.Surgery was performed using a titanium elastic nail (depuy, synthes, paoli, pa, usa).The follow-up visits were at two, six and 12 weeks.The mean follow-up period was unknown.The following complications were reported as follows: 1 patient had iatrogenic perforation of the postero-lateral cortex of the clavicle which was noted on the post-operative cranial oblique view radiograph and the nail was repositioned the following day (figure 9).1 patient re-injured the operated clavicle one week after the initial surgery resulting in a haematoma at the fracture site.The haematoma was drained in theatre and work-up for infection yielded a negative result.An unknown number of patients had a medial nail prominence evident at 12-week follow-up visit.This report is for an unknown synthes titanium elastic nails.This report is for one (1) titanium elastic nail.This is report 2 of 2 for (b)(4).

• 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: 11784323
• MDR Text Key: 249288344
• Report Number: 8030965-2021-03626
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 04/12/2021
• 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