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

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

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Smekal, vinzenz et al (2009).Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures¿a randomized, controlled, clinical trial.J orthop trauma, 23:106¿112.This report is for unknown nail / unknown quantity / unknown lot.(other number) udi: unknown part number, udi is unavailable.(b)(6).(b)(4).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 literature article: smekal, vinzenz et al (2009).Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures - a randomized, controlled, clinical trial.J orthop trauma, 23:106-112.The goal of the present study was to compare elastic stable intramedullary nailing (esin) with nonoperative treatment of fully displaced midshaft clavicular fractures in adults in a randomized, controlled, clinical trial with a 2-year follow-up.Sixty patients (52 men and 8 women) between 18 and 65 years of age participated and completed the study.They were randomized to either operative or nonoperative treatment with a 2-year follow-up.Thirty patients (26 men and 4 women) were treated with a simple shoulder sling and 30 patients (26 men and 4 women) with esin within 3 days after trauma.In the nonoperative group, patients received a simple shoulder sling.In the operative group, surgery was performed within the first 3 days after trauma using general anesthesia.Antibiotics were given preoperatively as a single shot.Patients were placed in a supine position.A small skin incision (1-2 cm) was made approximately 1 cm lateral of the sternoclavicular joint, and the anterior cortex was opened with a reamer.2.5-mm titanium endomedullary nails were used in male patients and 2-mm titanium endomedullary nails in female patients.Closed reduction was performed under fluoroscopic control.If closed reduction failed, an additional incision was made above the fracture site for direct manipulation of the main fragments.The medial end of the nail was cut off as short as possible at the insertion site.Postoperatively, the patients were given a simple sling but were encouraged to start with pain-dependent mobilization immediately and to discard the sling as soon as possible.Patients were discharged from the hospital on the day after surgery.Load bearing was not recommended before osseous consolidation.Once fracture union was achieved, implant removal was offered to all patients.Complications: two (2) patients required implant removal due to mild discomfort at the medial insertion point.This report is for an unknown nail.This is report 1 of 2 for (b)(4).

• 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: 5586797
• MDR Text Key: 42989956
• Report Number: 2520274-2016-12119
• Device Sequence Number: 1
• Product Code: JDS
• 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
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/19/2016
• 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