MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Model Number	04.503.228.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported patient underwent a craniotomy with insertion of electrode array on (b)(6) 2018.While the surgeon as inserting one (1) 6mm and two (2) 8mm matrixmidface screws into the housing for the array, the screw head came off.The remaining portion of the screw remains embedded in patient¿s bone.Surgery was completed successfully with an unspecified delay.Concomitant device reported: non-synthes electrode array (part number unknown, lot number unknown, quantity 1).This report is for one (1) 6mm matrixmidface screw.This is report 3 of 3 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM
• 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: 7904344
• Report Number: 2939274-2018-53933
• Device Sequence Number: 1552385
• Product Code: DZL
• UDI-Device Identifier: 10887587019208
• UDI-Public: (01)10887587019208
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/31/2018

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
• Operator of Device: Health Professional
• Device Model Number: 04.503.228.01
• Device Catalogue Number: 04.503.228.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/24/2018
• Patient Sequence Number: 1
• Patient Age: 22 YR