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

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

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Scar Tissue (2060)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: fixing simple olecranon fractures with the olecranon osteotomy nail (oleon); nij, s., graeler, h., bellemans, j.(2011).Fixing simple olecranon fractures with the olecranon osteotomy nail (oleon).Oper orthop traumatol 23:438-445.This article described the surgical technique of and the clinical experience with the olecranon osteotomy nail (synthes).Between (b)(6) 2009 and (b)(6) 2011, 21 patients (8 male and 13 female ages ranging from 20-85 years with an average of 42 years) were treated with the olecranon osteotomy nail.A total of 6 complications were observed.One patient experienced a peri-implant fracture that required revision.Three patients experience decreased mobility as a result of ectopic ossification and one patient developed an arthrofibrotic elbow.This report is 1 of 2 for complaint (b)(4).This report is for an unknown olecranon osteotomy nail.A copy of the journal article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Nij, s., graeler, h., bellemans, j.(2011).Fixing simple olecranon fractures with the olecranon osteotomy nail (oleon).Oper orthop traumatol 23:438-445.This report is for an unknown olecranon osteotomy nail.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3790911
• MDR Text Key: 15361326
• Report Number: 2520274-2014-11202
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• 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: 04/09/2014
• 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