MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM; BONE PLATE

Model Number 04.511.225.01

Device Problem Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event- unknown date.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 Description

It was reported that on (b)(6) 2019, the patient experienced nonunion of the maxilla.There were probably 18 screws loosen.Maxilla was re-plated, nonunion was cleaned out, debrided back to the bleeding bone.The surgeon had to move the maxilla forward too far which put under stress on the hardware.The original date of implant was on (b)(6) 2019.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.Concomitant device report: trumatch 3d plate (part # sd980.014, lot # unknown, quantity 1) this report is for one (1) 1.85mm ti matrix screw self-drilling/5mm.This is report 5 of 9 for (b)(4).This complaint is a continuation from the linked complaint (b)(4) for the additional devices.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Event occurred on an unknown date in 2019, not (b)(6) 2019.Facility information captured, and contact updated to reflect physician.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.

• Brand Name: 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8640870
• MDR Text Key: 146081155
• Report Number: 2939274-2019-58263
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587023618
• UDI-Public: (01)10887587023618
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.511.225.01
• Device Catalogue Number: 04.511.225.01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Patient Sequence Number: 1
• Treatment: TRUMATCH MIDFACE/MANDIBLE 3D PRINT; TRUMATCH MIDFACE/MANDIBLE 3D PRINT
• Patient Outcome(s): Required Intervention