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); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: gwo, gxr.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.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 02, 2019, the surgeon was screwing the matrixneuro self drilling screws to the native bone flap by hand and the two (2) screw heads were sheared and cracked.Fragments were generated but was easily removed.There was no surgical delay.Procedure was successfully completed.Patient status was good.  concomitant device reported: unknown plates (part # unknown, lot # unknown, quantity # 4), unknown screws (part # unknown, lot # unknown, quantity # unknown).  this is report 1 of 2 for (b)(4).

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.Investigation summary: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachments (1 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image didn¿t not show enough clarity to show screw heads being sheared/cracked and therefore is unconfirmed.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: date of implant retracted actual device not received; only x-ray images were received.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.

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.The device was received, the investigation is in progress, 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.

• 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
• MDR Report Key: 8950468
• MDR Text Key: 156315151
• Report Number: 2939274-2019-60244
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587018324
• UDI-Public: (01)10887587018324
• Combination Product (y/n): N
• PMA/PMN Number: K123723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2019

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
• Device Operator: Health Professional
• Device Model Number: 04.503.104.01
• Device Catalogue Number: 04.503.104.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/05/2019; 09/09/2019
• Supplement Dates FDA Received: 09/06/2019; 10/01/2019
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWS: TRAUMA