MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Patients informations: 39 patients (29 boys,10 girls; mean age 8.0 +/-2.0 years).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: choi wy, et al (2021), leg length discrepancy, overgrowth, and associated risk factors after a pediatric tibial shaft fracture, journal of orthopaedicsand traumatology, volume 22, pages 1-7, (south korea).This study was performed to investigate leg length discrepancy (lld), overgrowth, and associated risk factors after pediatric tibial shaft fractures.Between january 2003 and november 2018, 103 patients younger than 14 years of age with unilateral tibial shaft fracture and a minimum follow-up of 24 months were included in the study.There were 75 boys and 28 girls with a mean age of 7.1 years.Casting was performed on 64 patients.Meanwhile, 39 patients (29 boys,10 girls; mean age 8.0 +/-2.0 years) underwent titanium elastic nailing using an unknown synthes titanium elastic nail.The mean follow-up duration was 3.9 ± 2.0 years.Complications specific with the synthes device were reported as follows: 17 patients had leg length discrepancy of more than 1 cm.19 patients had an overgrowth of more than 1 cm.For the following patients, the author¿s did not specify if they were implanted with a synthes device or were treated with cast.Thus, complications will be reported as follows: 5 patients had a leg length discrepancy of more than 2 cm.7 patients had an overgrowth of more than 2 cm.3 patients underwent epiphysiodesis.1 patient underwent tibial lengthening using an ilizarov external fixator.1 patient underwent hemiepiphysiodesis because of posttraumatic genu valgum.This report is for the unknown synthes titanium elastic nail.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 11856446
• MDR Text Key: 251726338
• Report Number: 8030965-2021-04070
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/23/2021

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: 04/23/2021
• Initial Date FDA Received: 05/20/2021
• 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