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

Model Number	RETROFUSION SCREW, 20MM
Health Effect - Clinical Codes	Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2020
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 when inserting the retrofusion screw into the phalanx, the screw broke in half.The broken half remains in the patient.This was a hammertoe / plantar plate repair; they completed the case using suture in the joint to pull the soft tissue together to aid in the fusion o f the joint., no more anchors were used and no additional incisions were needed.Inserting the screw into the phlanax, the screw broke in half, the screw remains in the patient.No patient information was available.

• 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: 10217901
• Report Number: 1220246-2020-01937
• Device Sequence Number: 2120937
• Product Code: HWC
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 07/01/2020

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: 10/31/2023
• Device Model Number: RETROFUSION SCREW, 20MM
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10258728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/01/2020
• 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