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

Model Number 04.503.226.01

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Additional classification code: jey.Explant and implant date not applicable since it broke intraoperatively.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 manufacture date is unknown.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 a patient had an unknown procedure on (b)(6) 2018.The surgeon went to put in a 6mm self-drilling matrix midface screw into the zygomatic frontal bone and the screw head split into two pieces.There was a delay in surgery by 5 minutes by trying to get the broken screw out of the bone.A needle driver was used to manually remove screw from patient and inserted a new one.The head of the screw was retrieved and shaft was retained.The surgery was completed successfully.Concomitant device: 1 qty, part number: 04.503.373, lot number unknown.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This date was incorrectly reported a 4/6/2018 in the initial report.The correct date is 4/5/2018.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

Date device returned to manufacturer.A product investigation was conducted.The 04.503.226 titanium matrixmidface screw with unknown lot number was returned and reported to have broken during surgery.Upon visual inspection, this condition is confirmed; a portion of the screw head was returned without the shaft or the remainder of the screw.This complaint condition was likely caused by contact with the plate during insertion or by applying excessive force during insertion; however, this complaint is not likely a result of any design or manufacturing related deficiency.The broken investigation flow was followed for this investigation.No new malfunctions were observed during the course of this investigation.The 04.503.226 titanium matrixmidface screw is an instrument routinely used in the matrixmidface plating system.Relevant drawing was reviewed for this investigation.No dimensional check can be performed as all that was returned for investigation was a fragment of the screw head.The condition of the returned device does agree with the complaint description.A material or hardness check was not able to be performed as not enough material was returned for investigation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on these investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
• 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: 7464588
• MDR Text Key: 107075682
• Report Number: 2939274-2018-51935
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• 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,Followup,Followup
• Report Date: 04/05/2018

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: 04.503.226.01
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/15/2018; 06/01/2018
• Supplement Dates FDA Received: 05/15/2018; 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 32 YR