MAUDE Adverse Event Report: SYNTHES MONUMENT TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 04.503.226.01

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Additional product code: jey (b)(4).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.(b)(4).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 three (3) titanium (ti) matrixmidface screws broke during a facial fracture repair involving the orbital rim on (b)(6) 2017.As the surgeon attempted to implant the first screw, it broke at the head.The surgeon removed additional bone around the shaft in order to remove the broken shaft.No fragments remained in the patient¿s bone.Subsequently, another screw was successfully implanted.The next screw to be implanted also broke at the head, and part of the shaft remains embedded.A third implanted screw broke upon removal; at this point in the procedure the surgeon decided to shift the plate due to placement preference.This required the screw to be backed out.When the surgeon backed out the screw, the screw head broke off and part of the shaft remains embedded in the bone.There was a reported surgical delay of fifteen minutes related to attempts to remove broken screw fragments.No additional x-rays were required.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: matrix midface screwdriver (part number unknown, lot number unknown, quantity 1), plate (part number unknown, lot number unknown, quantity 1) this report is for one (1) titanium matrix midface screw self-drilling 6mm this is report 2 of 3 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6997974
• MDR Text Key: 90959556
• Report Number: 1719045-2017-11150
• Device Sequence Number: 1
• Product Code: DZL
• 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: Other
• Type of Report: Initial
• Report Date: 10/12/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/02/2017
• 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
• Patient Outcome(s): Required Intervention