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); Deformity/ Disfigurement (2360); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown elastic nails/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: pogorelic, z., vodopic, t., jukic, m., and furlan, d.(2019), elastic stable intramedullary nailing for treatment of pediatric femoral fractures; a 15-year single centre experience, bulletin of emergency and trauma, vol.7 (2), pages 169¿175 (croatia).The aim of this retrospective study is to evaluate the clinical and radiological outcomes and complication rates of femoral fractures treated by esin in children in a cohort of 103 children over the past 15 years to underline the safeness and efficiency of this technique.Between may 2002 to may 2018, a total of 103 patients (76 male and 27 female) with a median age of 9 (3-17) years were included in the study.Surgery was performed using a titanium intramedullary nails (ten synthes® gmbh, oberdorf, switzerland).Each fracture was treated using two flexible nails of the same diameter.All the patients were regularly followed clinically and radiographically 7 days, and then 1, 3, 6 months after index surgery.The mean follow-up was 92 (3-188) months.The following complications were reported as follows: 3 patients had entry site skin irritations.2 patients had valgus angulations.1 patient had varus angulation.At follow-up all patients went on to osseous union and regained a full range of movement after removal of intramedullary nails.1 patient had a migration of the nail.A (b)(6)-year-old male patient developed refracture at three weeks after removal of the nails.Closed reduction and osteosynthesis with titanium nails were performed.At follow-up he had uneventful course.A (b)(6)-year-old female patient was reoperated due to valgus angulation of the distal femur following titanium intramedullary nailing.Osteotomy and plate fixation were performed.A (b)(6)-year-old male patient had a delayed union.This report is for an unknown synthes elastic nails.It captures reported events of skin irritation, valgus angulation, varus angulation and removal of nails.This is report 2 of 7 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10766763
• MDR Text Key: 217120026
• Report Number: 8030965-2020-08458
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: HR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 10/08/2020
• 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