MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; SCREW FIXATION INTRAOSSEOUS

Model Number	04.503.225.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A very small fragment of the ti matrixmidface screw self-drilling 5 mm (p/n 04.503.225.01, lot # unk) screw head, approximately 2.6 mm x 1.0 mm x 0.9 mm (ca818), was returned.The rest of the screw fragment(s) was not returned.The transverse fractures were at the neck of the screw and the mid-line of the cruciform drive.Dimensional inspection could not be conducted due to post manufacturing damage and missing fragments.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the ti matrixmidface screw self-drilling 5 mm (p/n 04.503.225.01, lot # unk) as only a fragment of the broken screw was returned.The transverse fractures were at the neck of the screw and the midline of the cruciform drive.No definitive root cause could be determined.It is possible that excessive torque / force was encountered.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the 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.
Event or Problem Description
It was reported that on (b)(6) 2019, during on a zygomaticomaxillary complex fracture procedure, while the surgeon was screwing the titanium matrixmidface screws self-drilling into an unknown 8 mm orbital rim plate, as the screws self-drilling was close to completion, a piece of the screws self-drilling chipped off.The sales consultant had the little piece of the screw head and a very small fragment.The procedure was completed using additional self-drilling screws.Fragments generated from a broken device and were removed.There was no surgical delay.Surgery successfully completed.Patient outcome completed.Concomitant devices reported: unk - plates: matrix orbital (part # unknown; lot # unknown; quantity 1).This report is for one (1) ti matrixmidface screw self-drilling 5 mm.This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8945316
• Report Number: 2939274-2019-60204
• Device Sequence Number: 2520911
• Product Code: DZL
• UDI-Device Identifier: 10887587019147
• UDI-Public: (01)10887587019147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: 04.503.225.01
• Device Catalogue Number: 04.503.225.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/29/2019
• Patient Sequence Number: 1
• Patient Age: 50 YR