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

Model Number	RETROFUSION SCREW, 20MM
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	07/03/2019
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 device was reported to have been discarded.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 hammertoe procedure, the surgeon drilled and prepped the bone per the surgical technique.Upon insertion of the retrofusion screw, ar-4157-20, the surgeon met resistance.He backed out the screw and re-drilled to try again.Again, as he was attempting to engage the screw, he met resistance and was having difficulty getting the screw to advance.He again attempted to back the screw out but this time, the screw snapped where the threads meet the shaft of the screw.The surgeon used a synthes screw removal kit to core around the screw making a dorsal cut in the bone in order to remove it.All fragments were removed from the patient and discarded.The surgeon used a k-wire for fixation to complete the case with no adverse effect to the patient.Patient is a female, (b)(6).

• 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: 8817483
• Report Number: 1220246-2019-01214
• Device Sequence Number: 13539015
• Product Code: HWC
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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 Expiration Date: 12/31/2021
• Device Model Number: RETROFUSION SCREW, 20MM
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10106198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/23/2019
• 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