MAUDE Adverse Event Report: SYNTHES GMBH; EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Model Number	400.809.96
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Using the synthes mod hand set, during placement the surgeon noted that a 1.5 mm cortex 9 mm screw head completely broke off after placement.No harm and screw secured with operating room (or) leadership.

• Brand Name: NA
• Common Device Name: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 16459685
• Report Number: 16459685
• Device Sequence Number: 11386116
• Product Code: MQN
• UDI-Device Identifier: 10886982203687
• UDI-Public: (01)10886982203687
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2023
• Report Date (Section F): 01/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: 400.809.96
• Device Catalogue Number: 40080996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/31/2023