MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,34MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,4.0 STD,34MM LGTH
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/12/2019
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 a procedure, the surgeon was attempting to remove a 4.0 headless screw from the proximal tibia with a t10 hexalobe driver, ar-8737-38, and the tip broke off into the head of the screw.The tip was able to be removed from the head with no issue.The surgeon then used a cannulated t10 hexalobe driver, ar-8737-26, to finish the removal of the tip of the driver which became twisted.The screw was able to be removed with the second driver with no issue to the patient.Additional information requested.Additional information provided (b)(6) 2019: the patient underwent a procedure on (b)(6) 2019 where a 4.0 headless screw, ar-8740-34h, was implanted.Shortly after, the patient began experiencing pain and had to have a second surgery to have the screw removed on (b)(6) 2019.Pain is the only symptom the patient was experiencing and it was the only device removed during the revision procedure.No hardware was put in its place.

• Brand Name: COMPR FT SCRW,4.0 STD,34MM LGTH
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8739448
• Report Number: 1220246-2019-01178
• Device Sequence Number: 2473601
• Product Code: HRS
• UDI-Device Identifier: 00888867127722
• UDI-Public: 00888867127722
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: COMPR FT SCRW,4.0 STD,34MM LGTH
• Device Catalogue Number: AR-8740-34H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/27/2019
• 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