MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM; SCREW FIXATION INTRAOSSEOUS

Model Number	04.503.226.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: jey.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a case of a maxilla resection with fibula bone as the flap on (b)(6) 2019, a drill bit was used to implant nine (9) 6mm screws into the bone.Two (2) screw heads popped off/ broke and the screw shaft remained in the bone.It was further reported that the fibula flap died, and the surgical team had to remove it.This was determined to not be caused by the screw breaking off.Procedure was completed successfully with a three (3) minute delay.Current patient status is unknown.Concomitant medical product: matrix 1.1mm drill bit (part: 03.503.246, lot: unknown, quantity: 1).This report is for a titanium (ti) matrixmidface screw.This is report 1 of 2 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8288460
• Report Number: 2939274-2019-56136
• Device Sequence Number: 16779285
• Product Code: DZL
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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: 04.503.226.01
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/30/2019
• Patient Sequence Number: 1