MAUDE Adverse Event Report: ARTHREX, INC. VAL SCREW, TI, 1.6 X 9MM; PLATE, FIXATION, BONE

Model Number	VAL SCREW, TI, 1.6 X 9MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an (b)(6) 2020 metacarpal fx procedure the surgeon was using an ar-18716v-09 screw which did not want to lock into the ar-18716p-03 plate (lot 04521913).The surgeon used another one and it finally locked into the plate and the case was finished.To prep the bone the surgeon had used the 1.2mm recommended drill.The lot number is unknown because the screw was from the distributor's mini cfs tray (#2) and screw lots are not recorded in the tray.Approximately a week later the surgeon the surgeon reported to the sales representative that the surgeon had to revision that fracture again because that same locking screw backed out.The revision procedure took place (b)(6) 2020 at the same facility by the same surgeon.During the revision the ar-18716v-09 screw was explanted and a replacement screw of the same size was implanted.Device will not be returned as the device was discarded by the surgeon during the revision procedure.

• Brand Name: VAL SCREW, TI, 1.6 X 9MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10563428
• Report Number: 1220246-2020-02194
• Device Sequence Number: 2671203
• Product Code: HRS
• UDI-Device Identifier: 00888867313668
• UDI-Public: 00888867313668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: VAL SCREW, TI, 1.6 X 9MM
• Device Catalogue Number: AR-18716V-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other