MAUDE Adverse Event Report: SYNTHES USA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported a synfix trial spacer (part/lot number: unknown/unknown) and handle (part/lot number: unknown/unknown) that broke during insertion.The surgeon was able to retrieve all the broken fragments with no extended surgical time or injury to the patient.The surgery was successfully completed.This report is for an unknown trial spacer.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown trial spacer.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: w. lindenmuth ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3576857
• MDR Text Key: 4037067
• Report Number: 2520274-2014-00192
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1