MAUDE Adverse Event Report: SYNTHES MONUMENT TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; SCREW FIXATION INTRAOSSEOUS DRILLS, BURRS, TREPHINES & ACCESSORIES SIMPLE, POWER

Catalog Number 04.503.225.01

Device Problem Break (1069)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age, dob & weight not provided for reporting.Additional product code: jey (b)(4).Device malfunctioned intra-operatively and was not implanted / explanted device is not expected to be returned for manufacturer review/investigation.Concomitant device: battery powered screwdriver (part # unknown, lot # unknown, quantity 1), screwdriver (part # unknown, lot # unknown, quantity 1).Screw driver shafts (part # unknown, lot # unknown, quantity unknown), needle driver (part # unknown, lot # unknown, quantity 1), drill (part # unknown, lot # unknown, quantity 1), craniomaxillofacial plate (part # unknown, lot # unknown, quantity 1).(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, 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.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 screw head became warped (concave) during a lefort 1 procedure on (b)(6) 2017.When the screw was put into the plate, the screw head became warped (concave).The surgeon tried to back the screw out and the screwdriver would not engage the screw.They tried several ways to get it out and could not, which eventually lead to the screw head crumbling and breaking off.The surgeon first drilled the plate until it broke so he could access the screw more easily.It was further explained that the surgeon was trying to drill the plate off of the screw and that the break was an unintentional consequence of his efforts.He then used a screwdriver and a number of shafts (in case the tips of the screw drivers were stripped) to remove the screw; these methods did not work.The surgeon then used a needle driver which caused the head of the screw to crumble and break off of the shaft.Lastly, the surgeon drilled a larger hole in the patient's bone and used the needle shaft to twist the shaft fragment out.It was confirmed that the shaft of the screw was taken out along with all of the screw head pieces, and no remains of the screw were left in the patient.There was a reported surgical delay of 20-30 to get the pieces out, and because of the intraoperative events.The broken plate was replaced.No additional x-rays or other medical intervention required.The final construct included (4) l-plates and multiple screws to fit the l-plates.The surgery was successfully completed with no additional intraoperative events and the patient was reported to be stable at the end of the procedure.The broken screw was discarded and not available for investigation.This complaint involves one (1) device.Concomitant device: battery powered screwdriver (part # unknown, lot # unknown, quantity 1), screwdriver (part # unknown, lot # unknown, quantity 1).Screw driver shafts (part # unknown, lot # unknown, quantity unknown), needle driver (part # unknown, lot # unknown, quantity 1), drill (part # unknown, lot # unknown, quantity 1), craniomaxillofacial plate (part # unknown, lot # unknown, quantity 1) this report is 1 of 1 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS DRILLS, BURRS, TREPHINES & ACCESSORIES SIMPLE, POWER
• 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: 6941881
• MDR Text Key: 89248066
• Report Number: 1719045-2017-11050
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/19/2017

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: 04.503.225.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/11/2017
• 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