MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Model Number 04.503.104.01

Device Problems Break (1069); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: gwo, gxr.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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) 2020, during an unknown procedure, it was noticed that the ten (10) ti matrixneuro self-drilling 4mm screws were not sharp and were hard to insert.The screw heads were breaking off of the screws.Surgeon took out the screws and then redid the plating.There was a surgical delay of twenty-five (25) minutes.The procedure successfully completed.The patient outcome was unknown.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) ti matrixneuro screw self-drilling 4mm.This is report 8 of 10 for (b)(4).

• Brand Name: TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10541384
• MDR Text Key: 207182655
• Report Number: 2939274-2020-04153
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587018324
• UDI-Public: (01)10887587018324
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.104.01
• Device Catalogue Number: 04.503.104.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• 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
• Treatment: UNK - SCREWDRIVERS