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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.Irenberger, a, et al (2009) elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures¿a randomized, controlled, clinical trial.J orthop trauma, vol.23, no.2, pp:106-112.This report is for an unknown titanium endomedullary nail.(b)(4) revision surgery.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers 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 journal article: irenberger, a, et al (2009) elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures - a randomized, controlled, clinical trial.J orthop trauma, vol.23, no.2, pp:106-112.The objective of this study was to compare elastic stable intramedullary nailing (esin) with nonoperative treatment of fully displaced midshaft clavicular fractures in adults with a 2 year follow up.Sixty patients completed the study, 52 men and 8 women.The 2.5mm titanium endomedullary nails (synthes, (b)(6)) were used in male patients and 2mm titanium endomedullary nails in female patients.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.In 4 cases (13.3%), an additional incision at the fracture site was needed for fracture reduction.In 2 patients, implant removal was necessary due to mild discomfort at the medial insertion point.Fracture union was achieved in all patients of the operative group but in 1 patient as a delayed union after 32 weeks.Implant failure was observed in 2 patients after an additional adequate trauma, revision surgery was performed in both patients with an uneventful recovery.A medial nail protrusion, in 5 patients due to an anterior cutout and in 2 patients due to telescoping, caused painful skin irritation.In these cases, the nail had to be cut back under local anesthesia.Further healing was uneventful.This report is for an unknown titanium endomedullary nail.This is report 2 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5836652
• MDR Text Key: 50844405
• Report Number: 2520274-2016-13767
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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: 07/28/2016
• 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