MAUDE Adverse Event Report: ARTHREX, INC. RETROFUSION SCREW, 20MM; SCREW, FIXATION, BONE

Model Number	RETROFUSION SCREW, 20MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2019
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 pip joint fixation procedure; as the surgeon was completing the fdh/fhl extension and fixation of 2nd to 5th toe, the retrofusion screw, (b)(4), broke at the middle of the shaft; leaving broken pieces inside the proximal phalanx.The broken pieces were completely removed during the surgery using a screw extraction device made by another manufacturer.The bone hole was supplemented with bone from the other toes, and the 3rd toe on the right foot was fixed with a c wire.The surgery was completed, and no abnormalities were found in post-operative x-rays.The procedures for the 4th and 5th toes on the right foot and the 3rd to 5th toe of the left foot were changed to a procedure that utilizes c wires.
Additional Manufacturer Narrative
Complaint confirmed, the screw was found to be broken in two pieces.Likely causes include improper bone prep, prying/leveraging the device during insertion, continually applying torque when the device is not advancing.

• Brand Name: RETROFUSION SCREW, 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9585892
• Report Number: 1220246-2020-01575
• Device Sequence Number: 2436549
• Product Code: HWC
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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 Expiration Date: 04/30/2024
• Device Model Number: RETROFUSION SCREW, 20MM
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10305533
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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