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

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Reaction (2414)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: can complications of titanium elastic nailing with end cap for clavicular fractures be reduced?; frigg, a., rillmann, p., ryf, c., glaab, r., reissner, l.(2011).Can complications of titanium elastic nailing with end cap for clavicular fractures be reduced? clin orthop relat res 469:3356-3363.This study investigated whether (1) the complication rate could be reduced by cautious lateral advancement of the titanium elastic nails (tens), intraoperative oblique radiographs to rule out lateral perforation, and limited rom postoperatively; (2) fluoroscopy time could be reduced; and (3) shoulder function would be reasonable.44 patients with clavicular midshaft fractures treated with a ten using an end cap (synthes) from march 2006 to december 2009.There were 37 males and seven females with an aver aged of 31 years.Patients were divided into two groups: a (free range of motion post-op) and b (limited range of motion post-op).Complications in group a were 4 nail perforations, 1 revised nail breakage, 1 revised dislocation, and 3 minor complications such as pain.Complications in group b included 1 nail perforation, 1 revised non-union, 1 nail buckling due to post-op injury, and 2 medial skin irritations by the end cap.This report is 1 of 2 for (b)(4).This report is for an unknown titanium elastic nail.

Manufacturer Narrative

Date of event: frigg, a., rillmann, p., ryf, c., glaab, r., reissner, l.(2011).Can complications of titanium elastic nailing with end cap for clavicular fractures be reduced? clin orthop relat res 469:3356-3363.Additional device info: this report is for an unknown titanium elastic 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: 3790141
• MDR Text Key: 4446094
• Report Number: 2520274-2014-11199
• 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,Company Representative
• 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