MAUDE Adverse Event Report: SYNTHES USA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arthritis (1723); Unspecified Infection (1930); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Pain (1994); Non-union Bone Fracture (2369); Limited Mobility Of The Implanted Joint (2671)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: esposito, j., schemitsch, e., saccone, m., sternheim, a., and kuzyk, p., (2013).External fixation versus open reduction with plate fixation for distal radius fractures: a meta-analysis of randomized controlled trials.Injury, int.J.Care injured, 44, 409¿416.The authors conducted a systematic review and meta-analysis of randomized controlled trials comparing external fixation to open reduction internal fixation.Pooled mean differences were calculated for the following continuous outcomes: wrist range of motion; radiographic parameters; grip strength; and disabilities of the arm, shoulder, and hand score.Pooled risk ratios were calculated for rates of complications and reoperation.This article summarizes findings from other published articles regarding synthes devices (external fixator and plate) in which an unknown number of infections, reoperations, osteoarthritis, malunions, nerve deficits, complex regional pain syndrome, painful retained hardware, carpal tunnel syndrome, stiffness, and tendonitis were reported.The authors concluded there was little clinical difference between open reduction internal fixation with external fixation groups and plate fixation.This is report 1 of 2 for complaint (b)(4).This report is for an unknown external fixator.

Manufacturer Narrative

Device is used for treatment, not diagnosis.Injury, int.J.Care injured 44 (2013) 409¿416.Device is an unknown external fixation, quantity 1.Cannot be determined without a part number.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3651029
• MDR Text Key: 4200774
• Report Number: 2520274-2014-00872
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1