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

Catalog Number	AR-4157-20
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.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.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.Picture provided is not sufficient for cause determination.Without the actual device available for evaluation the cause of the event could not be determined from the information available.The most likely cause(s) of this type of event include improper bone preparation prior to insertion, over-torquing or leveraging the implant during insertion.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Remains in patient and piece discarded.
Event or Problem Description
It was reported that the screw broke in half during insertion into the bone.The broken half remains in the patient.The case was completed with k-wire.Procedure was a hammertoe procedure and the site was pre drilled per the rep present in case, the screw was getting tight during the insertion prior to breakage.Patient was reported to have hard bone.X-ray picture was provided to arthrex.

• Brand Name: RETROFUSION SCREW, 20 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6614560
• Report Number: 1220246-2017-00186
• Device Sequence Number: 13615480
• Product Code: HRS
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

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: 12/01/2021
• 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: 05/11/2017
• Initial Report FDA Received Date: 06/06/2017
• 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