MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM; SCREW FIXATION INTRAOSSEOUS

Model Number 04.503.224.01

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age or date of birth, and weight not available for reporting.Additional product code: jey.Device malfunctioned intra-operatively and was not implanted / explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was 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.

Event Description

It was reported that pieces of the head of a matrix midface screw were disintegrating during a zygomaticomaxillary complex fracture (zmc) repair on (b)(6) 2017.A resident surgeon was implanting a 4 mm screw into the zygomatic frontal suture when the head began to break apart and disintegrate.The screw was removed successfully and no fragments remained.There was a reported ten (10) minute delay to remove and replace this screw.Another screw was used.The final construct was a midface plate and screws.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: matrixmidface orbital rim plate 12 holes 0.7 mm thick (04.503.373, lot number unknown, quantity 1), screwdriver handle with hex coupling-medium (311.006, lot number unknown, quantity 1), matrixmidface screwdriver blade hex coupling self-retaining 96 mm 03.503.203, lot number unknown, quantity 1).This report is for one (1) titanium matrixmidface screw self-drilling 4 mm.This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7191889
• MDR Text Key: 97868338
• Report Number: 2939274-2018-50270
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587019116
• UDI-Public: (01)10887587019116(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.224.01
• Device Catalogue Number: 04.503.224.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1