MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0 TI MATRIXMANDBL SCR SELF-DRILLING/6; BONE PLATE

Model Number 04.503.506.01

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 august 5, 2021, the patient underwent for a surgery.Matrixmandible screws broke during surgery.The surgeon notified that three(3) 6mm self-drilling matrix mandible screw heads sheared off upon insertion into the bone.Another plate and extra screws were used b/c the screws broke.The broken fragments are retained in the patient.There was no surgical delay.The surgery was completed successfully.The patient outcome was unknown.Concomitant device reported.Unknown insertion instrument (part# unknown, lot# unknown, qty 1).Unk - plates: matrixmandible (part# unknown, lot# unknown, qty 1).This complaint involves three (3) devices.This report is for (1) 2.0 ti matrixmandbl scr self-drilling/6.This report is 1 of 3 for (b)(4).

• Brand Name: 2.0 TI MATRIXMANDBL SCR SELF-DRILLING/6
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12422287
• MDR Text Key: 271949512
• Report Number: 2939274-2021-05173
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587021409
• UDI-Public: (01)10887587021409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.506.01
• Device Catalogue Number: 04.503.506.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1