MAUDE Adverse Event Report: SYNTHES USA TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

Catalog Number 04.503.226.01

Device Problems Break (1069); Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

It was reported that the plastic surgeon was repairing a zygomatic complex (zmc) fracture on (b)(6) 2014 when the head of a 5.0mm matrix midface screw failed during insertion into the fracture suture.The head of the screw sheared off before the surgeon was able to tighten it completely.The screw head sheared off even with the bone so removal was not necessary.The surgeon was able to secure the 0.7mm orbital rim plate using additional screws, which he then pre-drilled.The head of the screw was subsequently lost.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis additional code: dzl.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: jodi temple ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3639861
• MDR Text Key: 15204575
• Report Number: 2520274-2014-00648
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K050608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 104