MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,4.5X 45MMCANN; PLATE, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,4.5X 45MMCANN
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2019
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 broken screw head that was removed was lost after being washed and will not be returning.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 during a tibial tubercle osteotomy procedure, as the surgeon was tightening the ar-8945-45ft low profile screw the head of the screw popped off.The rep stated the threads of the screw were holding fine, just the 2mm head popped off.The screw stayed implanted and the broken head of the screw was retrieved as it was not inserted into the bone.The implant was seated at a depth of 45mm.The bone quality was hard.The case was completed and an unplanned incision was not made.Additional information received on 06/12/2019: the bone was prepped with a 3.0 drill bit.The full length of the screw threads remains implanted in the tibia.The screw held and the surgeon was happy with the fixation so there were not any attempts made to remove the threaded portion of the screw.A second screw was not needed, and a graft was not used.The broken screw head that was removed was lost after being washed and will not be returning.

• Brand Name: LO-PRO SCRW,TI,4.5X 45MMCANN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8735075
• Report Number: 1220246-2019-01171
• Device Sequence Number: 2638444
• Product Code: HRS
• UDI-Device Identifier: 00888867053748
• UDI-Public: 00888867053748
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: LO-PRO SCRW,TI,4.5X 45MMCANN
• Device Catalogue Number: AR-8945-45FT
• Device Lot Number: 10156101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/26/2019
• 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
• Patient Age: 29 YR