MAUDE Adverse Event Report: SYNTHES (USA) MATRIXORTHOGNATHIC; SCREW, FIXATION, INTRAOSSEOUS

Model Number 04.511.226.01

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 02/24/2016

Event Type  malfunction  

Event Description

Surgeon attempted to implant 6mm x 1.85mm titanium self-drilling screw to right mandible.The top of the screw broke off.The body of the screw was removed and wasted.The broken part of the screw was successfully suctioned from patient's mouth.

• Brand Name: MATRIXORTHOGNATHIC
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES (USA); 1301 goshen parkway; west chester PA 19380
• MDR Report Key: 5500303
• MDR Text Key: 40323523
• Report Number: 5500303
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 04.511.226.01
• Device Catalogue Number: 04.511.226.01
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2016
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR