MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM; BONE PLATE

Model Number	04.503.226.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the surgeon was fixing the zmc fracture with a matrixmidface plate and screws.When fixing the third screw of fourth, at the end of the screwing, the screw head started to disintegrate.They were not able to remove it and left the screw in the patient, burring the head of the screw to make sure it was not sharp.There was a surgical delay of five (5) minutes.Concomitant device reported: unknown matrixmidface plate (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) ti matrixmidface screw self-drilling 6mm.This is report 1 of 1 for (b)(4).
Additional 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.Patient code 3191 used to capture additional information - surgical intervention; surgery prolonged 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 MATRIXMIDFACE SCREW SELF-DRILLING 6MM
• 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: 9168073
• Report Number: 2939274-2019-61304
• Device Sequence Number: 3642957
• Product Code: JEY
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: Health Professional
• Device Model Number: 04.503.226.01
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: MATRIXMIDFACE
• Outcome Attributed to Adverse Event: Required Intervention