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	11/13/2019
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 during a hammertoe repair procedure, the distal portion of the ar-4157-20 retrofusion screw (20 mm) snapped off while the surgeon was using the driver to insert the screw into the proximal phalanx, leaving just the proximal part of the screw inserted in the patient.The rep reported the broken fragment was retrieved and the surgeon had to switch surgical techniques and fixate with k-wires instead.The case was completed and a second surgery is not necessary.Additional information received on 11/21/2019: the rep reported the full screw was removed from the patient and will be returning for evaluation.The surgeon removed the screw by using a rongeur to turn the screw counter-clockwise to remove.Full removal of the screw caused the surgeon to have to resect more bone than they had initially wanted to.The bone was prepped by using the drill in the retrofusion disposable kit.The bone quality was hard.
Additional Manufacturer Narrative
Complaint confirmed, the screw broke in two pieces.The most likely causes include improper bone prep, misaligned insertion, prying/leveraging the device during insertion.The damages observed on the thread was most likely caused by tooling during the removal of the device.

• 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: 9443606
• Report Number: 1220246-2019-01465
• Device Sequence Number: 19440952
• Product Code: HWC
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 12/31/2023
• Device Model Number: RETROFUSION SCREW, 20MM
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10274153
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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