MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW; SCREW, FIXATION, BONE

Catalog Number	AR-1915SNF
Health Effect - Clinical Codes	Itching Sensation (1943); Scarring (2061); Skin Irritation (2076); Swelling (2091)
Date of Event	04/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (weight) were requested but not provided.This is the second of three submissions from the same patient event.The others are 1220246-2016-00354 ((b)(4)) and 1220246-2016-00356 ((b)(4)).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 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.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.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.Part remains in patient.
Event or Problem Description
It was reported that the patient had an internal brace atfl repair on (b)(6) 2016 with 2 ligaments reattached.During the revision the following arthrex products were implanted: ar-1678-cp (lot 300157), ar-1915snf (lot 10000657 and lot 51277742), ((b)(4) respectively).Patient states her ankle and joint work great and she has had no pain.Approximately the second week of (b)(6) 2016 the patient began to notice raised, irritated and itchy skin around the incision.The reaction extends past the incision in a strip around the ankle bone as well as the crease area where the ankle meets the foot.Patient's surgeon has directed patient to a dermatologist.Patient was seen by dermatologist on (b)(6) 2016.Dermatologist informed patient that the issue is more likely caused by some keloid scarring and not an allergic reaction.Dermatologist has injected steroid into some of the reactive area.On (b)(6) 2016 patient had follow up with the dermatologist.Slight improvement was noted in the small area that had received the steroid injection.On (b)(6) 2016 dermatologist injected the entire area.Patient will follow up with dermatologist in approximately 4 weeks.If there is no improvement dermatologist will perform a biopsy of the tissue at that time.Patient reiterated on 8/19/2016 that dermatologist believes the issue may be keloid scarring and not an allergic reaction.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5897928
• Report Number: 1220246-2016-00355
• Device Sequence Number: 556682
• Product Code: HWC
• UDI-Device Identifier: 00888867022676
• UDI-Public: 00888867022676
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• 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): 08/01/2016

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 Expiration Date: 06/01/2020
• Device Catalogue Number: AR-1915SNF
• Device Lot Number: 10000667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/23/2016
• 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
• Patient Age: 48 YR