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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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: park k., et al (2020) overgrowth of the femur after internal fixation in children with femoral shaft fracture¿a multicenter study, journal of orthopaedic trauma , volume 34, number 3, pages 1-6 (korea, south).This study aims to (1) to evaluate femur overgrowth after internal fixation and (2) to investigate clinical factors related to the overgrowth, including age, sex, fracture site, operation method (esin vs.Mipo), and fracture type (length-stable vs.Length-unstable).Between march 2005 and march 2015, patients with unilateral femoral shaft fractures treated by esin or mipo were recruited.A total of 87 children (64 males,23 females) with average age of 7 years, 1 month (range 4¿10 years) were included.Esin was performed with retrograde methods in all cases using a titanium elastic nails.Mipo was done using a locking plates (3.5 mm, synthes, paoli, pa) and usually 3 or 4 screws were used for each proximal and distal plate.Thirty-six children were treated by mipo, and 51 children were treated by esin.The average follow-up period was 46 months (range 24¿132 months).The following complications were reported as follows: in the esin group, overgrowth was 9.5 6 7.0 mm in patients with length-stable fracture and 11.2 6 7.8 mm in patients with length-unstable fractures postoperative shortening.In the mipo group, however, the overgrowth was 13.0 6 7.2 mm in patients with length-unstable fractures, and this was larger than the 8.1 6 7.5 mm of overgrowth in patients with lengthstable fractures postoperative shortening.This report is for an unknown synthes titanium elastic nails (ten).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 10749468
• MDR Text Key: 216649460
• Report Number: 8030965-2020-08268
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

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: 10/01/2020
• Initial Date FDA Received: 10/28/2020
• 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