MAUDE Adverse Event Report: ARTHREX INC. QUICKFIX SCREW,TI,CANNULATED ST,CANCELLOUS.,4.0X 36MM; PLATE, FIXATION, BONE

Catalog Number	AR-8740-36PTS
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The cause of the event is undetermined.Lot number was not provided so device history record review cannot be performed.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6), a male patient had a lapidus bunion repair on his left foot.He was having pain in the surgical site; the surgeon did an x-ray and saw a curlicue metal piece.There was a second surgery on (b)(6) 2017; the metal piece was removed.Two cross screws had originally been implanted; they had fused and were not removed.The piece was sent to pathology and then will be sent to risk management.The current condition of the patient is unknown.

• Brand Name: QUICKFIX SCREW,TI,CANNULATED ST,CANCELLOUS.,4.0X 36MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7033770
• Report Number: 1220246-2017-00437
• Device Sequence Number: 2037102
• Product Code: HRS
• UDI-Device Identifier: 00888867046412
• UDI-Public: 00888867046412
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• 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): 11/15/2017

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 Catalogue Number: AR-8740-36PTS
• Device Lot Number: UNKNOWN
• 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: 10/25/2017
• Initial Report FDA Received Date: 11/15/2017
• 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