MAUDE Adverse Event Report: SYNTHES USA; NAIL,FIXATION,BONE

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

Patient Problems Death (1802); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Weresh et al (1999).Pulmonary gas exchange during intramedullary fixation of femoral shaft fractures.The journal of trauma and acute care surgery.Volume 46(5), pages 863-868.This report is for an unknown synthes nail.(unknown quantity/unknown lot).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).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

This report is being filed after the subsequent review of the following literature article: weresh et al (1999).Pulmonary gas exchange during intramedullary fixation of femoral shaft fractures.The journal of trauma and acute care surgery.Volume 46(5), pages 863-868.This was retrospective review of a study data collected between october 1996 to september 1997.The purpose of the study was determine if intramedullary femoral nailing produces cause immediate worsening of pulmonary gas exchange in patients with femoral shaft fractures.The total study group consisted of (50 adult patients, 40 male and 10 female) diagnosed with femoral shaft fractures.The mean age was 30 +/- 15 (sd) years.Among 50 patients, intramedullary reaming of femur was performed in 38 patients and in remaining 12 patients, femur was unreamed.In 12 patients with unreamed femur, fracture was stabilized with solid synthes nails in 6 patients and cannulated synthes nails in other 6 patients.Three serial measurements of alveolar dead space fraction, vd/vt and alveolar-arterial oxygen gradient, a-a do2 were obtained immediately before femoral nailing (pre), 30 minutes after nailing (+30), and 120 minutes after nailing (+120).It was concluded that the process of femoral nailing does not cause enough pulmonary embolization to alter pulmonary gas exchange as measured by vd/vt and a-a do2.There was no product problem.Following complications were observed.1 patient died 37 hours postoperatively.The syndrome of fat embolism was confirmed by autopsy.A copy of the literature article is being submitted with this medwatch.This report is for an unknown synthes nail.This report is for one (1) device.This is report 1 of 2 for (b)(4).This report refers to death 37 hours postoperatively in 1 patient.The syndrome of fat embolism was confirmed by autopsy.

Manufacturer Narrative

Device used for treatment, not for diagnosis.(b)(6).

• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6926560
• MDR Text Key: 88703705
• Report Number: 2520274-2017-12355
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• 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?: No
• Date Manufacturer Received: 10/18/2017
• 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): Death