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

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment not diagnosis.Hulsmans, m., et al (2016) anteroinferior versus superior plating of clavicular fractures, j shoulder elbow surg, 25: 448-454.This report is for an unknown screw (non-locking),unknown quantity/unknown lot.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the subsequent review of the following article: hulsmans, m., et al (2016) anteroinferior versus superior plating of clavicular fractures, j shoulder elbow surg, 25: 448-454.Country of article: the netherlands.This was a retrospective analysis of 99 patients who underwent an open reduction and plate fixation as treatment for clavicular fractures.There were (2) treatment groups, 39 patients were treated with anteroinferior plate fixation and 60 patients received superior plate fixation.The purpose of this study was to determine the optimal plate position comparing implant-related irritation and the proportion of plate removal in patients with clavicular fractures undergoing plate fixation by an anteroinferior approach or a superior approach.The primary outcome parameter was implant-related irritation.The groups did not differ significantly in age, gender, or affected side.The only significant difference was seen in the length of the plates used in both groups, measured in number of holes, with a significantly longer plate length in the anteroinferior group.Implants used in the patients treated with the anteroinferior plate fixation include the va-lcp anterior clavicular plate (depuy synthes bv, amersfoort, the netherlands).Complications: superior plating group [implanted with unknown screw (non-locking)] serious injury/reportable malfunction.Implant breakage requiring revision surgery and bone graft (n=1).This report is 4 of 4 for (b)(4).This report is for unknown screw (non-locking), unknown quantity and unknown lot number.

• Type of Device: SCREW, 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: 5846746
• MDR Text Key: 51166167
• Report Number: 2520274-2016-13837
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• 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