MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Bone Fracture(s) (1870); Skin Irritation (2076); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Smekal, v., et al (2011).Elastic stable intramedullary nailing is best for mid-shaft clavicular fractures without comminution: results in 60 patients.Acta orthopadica, 42: 324-329.This report is for an unknown nail (titanium endomedullary) /unknown quantity/unknown lot.Part unknown, udi is unavailable.(b)(6).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following article: smekal, v., et al (2011).Elastic stable intramedullary nailing is best for mid-shaft clavicular fractures without comminution: results in 60 patients.Acta orthopadica, 42: 324-329.(b)(6).This was a prospective controlled study that compared elastic stable intramedullary nailing (esin) with non-operative treatment of displaced midshaft clavicular fractures.Between (b)(6) 2003 and (b)(6) 2007, 120 patients volunteered to participate.Of those, 112 patients completed the study (60 in the operative and 52 in the non-operative group).Patients in the non-operative group were treated with a simple shoulder sling.In the operative group, intramedullary stabilization was performed within 3 days of the trauma.The patient age range in the operative group was 36.8ᠱ2.6; there were 54 males and 6 females.The 2.5 mm titanium endomedullary nails (ten, synthes, (b)(4) , usa) in male and 2 mm tens in female patients were used.Radiographic union was assessed every 4 weeks on 20 degree cephalad anteroposterior and posterior anterior radiographs of the clavicle.Constant shoulder scores and dash scores (dash, disabilities of the arm, shoulder and hand) were assessed at final follow-up after 2 years.Complications (operative group): two (2) patients - delayed union without further surgical intervention.One (1) patient - deep infection (article did not state treatment given for infection).Five (5) patients -medial skin irritation without telescoping with the need for cutting back the nail under local anesthesia.One (1) patient - refracture (article did not state treatment given for refracture).This report is 1 of 2 for (b)(4).This report is for unknown nail (titanium endomedullary), unknown quantity and lot number.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 5605371
• MDR Text Key: 43539561
• Report Number: 2520274-2016-12164
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• 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