MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, CMC LIGAMENT RECONSTRUCTION; SCREW, FIXATION, BONE

Catalog Number	AR-1677BC-CP
Health Effect - Clinical Codes	Skin Discoloration (2074); Swelling (2091); Burning Sensation (2146); Impaired Healing (2378)
Date of Event	08/12/2016
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.It was stated in the event that the patient is extremely allergic to nickel.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.Lot number was not provided so device history record review cannot be performed.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.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 materials must be considered prior to implantation.If additional relevant information is received, a follow-up report will be submitted.Device remains in patient.
Event or Problem Description
It was reported that the patient underwent a tightrope fixation on her right hand in (b)(6) of 2016.Patient stated that since her surgery her incision site is taking a very long time to heal.In the last few weeks the patient has been experiencing a burning sensation around where the button was implanted.Patient reports that she has been experiencing redness and swelling at the surgery site.Patient reports that she is extremely allergic to nickel and has requested the composition information for her implant, which has been provided to her.

• Brand Name: IMPLANT SYSTEM, CMC LIGAMENT RECONSTRUCTION
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6610450
• Report Number: 1220246-2017-00191
• Device Sequence Number: 531306
• Product Code: HWC
• UDI-Device Identifier: 00888867096066
• UDI-Public: 00888867096066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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-1677BC-CP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/05/2017
• 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