MAUDE Adverse Event Report: ARTHREX, INC. QUICKFIX SCREW; PLATE, FIXATION, BONE

Catalog Number	AR-8930-10
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/01/2012
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 not returned for evaluation but remained in the patient therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The most likely cause of this type of event is a reaction of the patient to the material(s) implanted.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.This is the first complaint of this type for this part/lot combination.If additional relevant information is received, a follow-up report will be submitted.Device remains in patient.
Event or Problem Description
It was reported by patient that she had surgery on her right foot (b)(6) 2012 for decompression, osteotomy and bunionectomy of her great toe and little toe.During the procedure the following parts were implanted: (b)(4) (lot 13578a) and (b)(4) (lot 16e4y).Patient reports that she has been having reaction symptoms since surgery which physician has been treating over the past several years.Patient reports blisters in the great toe area.Patient has a known nickel allergy.

• Brand Name: QUICKFIX SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5837687
• Report Number: 1220246-2016-00314
• Device Sequence Number: 1426469
• Product Code: HRS
• UDI-Device Identifier: 00888867049147
• UDI-Public: 00888867049147
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K052614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/08/2016

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-8930-10
• Device Lot Number: 135783A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2016
• Initial Report FDA Received Date: 08/01/2016
• 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