MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: FEMORAL; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - nails: femoral/unknown lot.Part and lot numbers are unknown; udi number is 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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).

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: alobaidi a, et al.(2016), early and late intramedullary nailing of femur fracture: a single center experience, international journal of critical illness & injury science, volume 6, number 3, pages 143-147, (qatar).This retrospective study aims to describe the reamed intramedullary nailing (rimn) timing and hospital outcomes in trauma patients presenting with a femur fracture.Between january 2010 and january 2012, 307 patients who sustained trauma with single or bilateral femur fracture (shaft) and underwent intramedullary nailing (piriformis entry and close nailing) were included in the study.Patients were divided into two groups: group 1 (early); those whose femur fractures were treated with primary rimn at less than 12 hours of injury and group 2 (late); those whose femur fractures were treated at 12 hours or more.Group 1 included 156 patients with a mean age of 29+/-9 years, 149 of them were males.Group 2 included 151 patients with a mean age of 36 +/-18 years, 137 of them were males.These patients were implanted with either an unknown ao intramedullary nail or a competitor¿s device.Complications were reported as follows: (group 1: early treatment).4 patients had systolic blood pressure lower than 90mmhg.54 patients had systemic inflammatory response syndrome.3 patients had wound infection.1 patient had sepsis.1 patient had a fat embolism.1 patient had an adult respiratory distress syndrome.1 patient died.This patient had an isolated femur fracture complicated with fat embolism and adult respiratory distress syndrome.(group 2: late treatment).5 patients had systolic blood pressure lower than 90 mmhg.54 patients had systemic inflammatory response syndrome.1 patient had bedsore.8 patients had wound infection.2 patients had sepsis.1 patient had a fat embolism.2 patients had an adult respiratory distress syndrome.This report is for the unknown ao intramedullary nail.This is report 01 of 01 of (b)(4).

• Brand Name: UNK - NAILS: FEMORAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9757585
• MDR Text Key: 189321422
• Report Number: 8030965-2020-01447
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

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: 02/05/2020
• Initial Date FDA Received: 02/26/2020
• 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