MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; BONE PLATE

Model Number	04.503.225.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 on (b)(6) 2020, the surgeon was implanting a 5mm midface screw into the zygoma and the threaded portion of the screw broke off from the head of the screw.Two (2) out of the matrix midface set broke off during the surgery.The bottom of the screw remained in the patient.Another remb drill was needed for the procedure.The surgeon had to drill at a different angle and put in another screw.There was a surgical delay of ten (10) minutes.The procedure was successfully completed.The patient was stable after the procedure.Concomitant devices reported: ti matrixmidface screw self-drilling 5mm (part number 04.503.225.01, lot unknown, quantity 1).This report involves one (1) ti matrixmidface screw self-drilling 5mm.This is report 2 of 2 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9923367
• Report Number: 2939274-2020-01717
• Device Sequence Number: 19665552
• Product Code: JEY
• UDI-Device Identifier: 10887587019147
• UDI-Public: (01)10887587019147
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 04.503.225.01
• Device Catalogue Number: 04.503.225.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR