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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; NAIL,FIXATION,BONE Back to Search Results
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).
 
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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 Key11784323
MDR Text Key249288344
Report Number8030965-2021-03626
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
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
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 04/12/2021
Initial Date FDA Received05/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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