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

Catalog Number	AR-4157-20
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.Without the actual device available for evaluation the cause of the event could not be determined from the information available.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a hammertoe correction procedure, the surgeon prepped the patient's bone using proper technique using the disposable kit.When he went to insert the 20mm retrofusion screw, the screw broke in half.The tip of the screw was retrieved and a coring reamer was used to expose enough so that the surgeon could grab the screw with pliers and twist the body of the screw out.Bone grafting and a k-wire were used to complete the case with no adverse effect to the patient.

• Brand Name: RETROFUSION SCREW, 20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7365034
• Report Number: 1220246-2018-00100
• Device Sequence Number: 1125283
• Product Code: HRS
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: 09/01/2022
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10166080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/23/2018
• 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