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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown locking screw, unknown quantity, unknown lot.Other number: udi: unknown part number, udi is unavailable.The investigation could not be completed and 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: volgas, d.And dreger, t.K.(2017) the use of mesh plates for difficult fractures of the patella.J knee surg 2017;30:200-203.A retrospective review of patellar fractures treated with a locking mesh plate at a level i trauma center was conducted.One-hundred and five (105) patients were identified who had undergone operative management of a displaced patella fracture between january 2011 and december 2015.The radiographs of these patients were reviewed to identify which patients underwent treatment with a mesh plate.Sixteen (16) patients (6 males and 10 females) who had undergone fixation with a mesh plate were identified, and these patients serve as the basis of this review.Mean age was 47 years, ranging from 19 to 79 years.Nine patients underwent primary open reduction internal fixation (orif) and seven underwent mesh plate fixation for failed orif of a patella fracture.A 2.7-mm variable angle locking mesh plate (depuy synthes trauma) was used for comminuted patella fractures which were not amenable to cannulated screw fixation and tension bandwiring.Complications included: there was one failure of mesh plating that was revised and went on to successful union.This was a distal pole fracture with failure of the locking screws.This is report 2 of 2 for (b)(4) this report is for unknown locking screws.

• Type of Device: SCREW, 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: 6536608
• MDR Text Key: 74166847
• Report Number: 2520274-2017-11559
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• 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): Required Intervention