MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Unspecified Infection (1930); Irritation (1941); Discomfort (2330); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A total of 80 patients who were randomized to operative stabilization either by pediatric orthopedists (group a, 40 cases) with 29 males and 11 females or by non-pediatric orthopedists (group b, 40 cases) with 25 males and 15 females.Date of event unknown.Implanted date: unknown.Explanted date: unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.[(b)(4) literature article.Pdf].

Event Description

This report is being filed after the review of the following journal article: zheng et al.(2018).Comparison of the outcomes of pediatric tibial shaft fractures treated by different types of orthopedists: a prospective cohort study.International journal of surgery.Volume 51, pages 140-144.(china).The objective of this study was to compare the outcomes of pediatric tibial shaft fractures treated with unknown synthes titanium elastic nail (ten) by pediatric orthopedists and non-pediatric orthopedists.This prospective study initially involves 90 children with tibial shaft fractures; 10 were lost to follow-up.A total of 80 patients who were randomized to operative stabilization either by pediatric orthopedists (group a, 40 cases) with 29 males and 11 females or by non-pediatric orthopedists (group b, 40 cases) with 25 males and 15 females from april 2010 to may 2015.All patients were placed in supine decubitus position and given general anesthesia.Closed reduction of the fracture was attempted initially in all patients; two ten¿s will be used, if failed attempts of closed reduction, open reduction with a small lateral incision was performed; two ten¿s will also be used.In patients requiring fixation of the fibula one kirschner wire or one titanium elastic nail of adequate size was inserted percutaneously from distal to proximal with the insertion point above the metaphysis.During operation, 37 fractures of group a were successfully closed reduction and 3 fractures failed while 29 were successful and 11 failed in group b.After surgery, a total of 17 complications was recorded, 9 from group a and 8 from group b.Follow-up visits were made at 2, 4, 12, 24 weeks and then every three months interval after discharge.Complications were reported as follows: three patients from group a and two from group b experienced nail irritation, two patients from group a and one patient from group b had superficial infection, one patient from group a and two from group b experienced limb shortening, then three patients from group a and two from group b had limb lengthening.Lastly, one patient from group b experienced delayed union.This report is for an unknown synthes titanium elastic nail (ten).This report is 1 of 1 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7515947
• MDR Text Key: 108349336
• Report Number: 8030965-2018-53777
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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: 04/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention